Impact of Waist Circumference Measurement

Philippine Journal of Internal Medicine

Original Article

Impact of Waist Circumference Measurement Variation on the Diagnosis of Metabolic Syndrome Michelle V. Lemoncito, M.D., Elizabeth Paz-Pacheco, M.D., Mary Anne Lim-Abrahan, M.D., Gabriel Jasul, Jr., M.D., Irish Thiele Isip-Tan, M.D., Cherry Mae Sison, M.D.

Abstract Introduction: While waist circumference (WC) is widely used as an index for visceral fat accumulation and purportedly the primary pathology responsible for the metabolic syndrome (MS), its proposed cut-off value varies depending on the disparate diagnostic criteria used as well as on the gender, race and ethnic group being evaluated. Due to the strong association between MS and central obesity, waist circumference should be incorporated into the routine physical exam when assessing cardiovascular disease and diabetes risk. Currently however, there is no standard location for the measurement of WC. On literature review, we found no scientific rationale for preferring any one WC site to the others hence, this study. Objective: This study aims to (1) determine waist circumference measurement variations among MS patients, (2005 NCEP-ATP III/AHA/NHLB criteria), at three levels: (A) umbilical level, (B) midline level (between the inferior margin of the ribs and the superior border of the iliac crest) and (C) level of the superior border of the iliac crest.

the study (56% females). Both males and females were obese stage 1 (25.5 kg/m2 and 26.7 kg/m2 respectively). The mean WC measurements at level A in men was 92.9 cm (81.36 – 104.44 cm) and 93.83 cm (83.4 – 104.26 cm) in women; at level B, the mean WC in men was 90.73 cm (75.49 – 105.97 cm) and 91.51 cm (80.62 – 102.4 cm) in women; and at level C, the mean WC in men was 93.5 cm (81.97 – 105.03 cm) and 95.12 cm (85.11 – 105.13 cm) in women. Results showed that WC measurements at three levels did not significantly differ among MS patients when stratified to age and sex. However, when waist circumference was measured at three levels among all patients with MS, there was significant difference in WC taken at level B and level C (Sig = 0.009). Waist circumference at level A was similar and less variable to WC level B than WC at level C.

Research Design and Methods: A cross-sectional analytical study among adult patients, aged 40 to 69 years, diagnosed with MS using 2005 NCEP-ATP III/AHA/ NHLB criteria seen at the Philippine General Hospital, as part of the Asia-Oceania Survey on Metabolic Syndrome and Diabetes initiated by the Japan Diabetes Society.

Conclusions: Among patients with MS as defined by NCEPATP III/AHA/NHLB criteria, waist circumference at level B (midpoint level between the lower ribs and superior border of the iliac crest) was smaller than waist circumference at level A (umbilical level) and smaller than level C (superior border of the iliac crest) (WCB < WCA < WCC). There was greater variability in mean WC measurements at level B and level C. Mean WC measurements at level A (umbilical level) and level B (midpoint level) were similar and less variable and may be a better waist circumference measurements to level C (superior border of the iliac crest).

Results: A total of 187 MS individuals were included in

Keywords: metabolic syndrome, waist circumference

Introduction

mellitus (DM). According to the 2003 National Nutrition and Health Survey (NNHES), 1 the prevalence of MS among Filipinos is 11.9 percent by National Cholesterol/Adult Treatment Panel III (NCEP/ATP III) criteria, 2 14.5 percent by International Diabetes Federation (IDF) criteria and 18.6 percent by 2005 National Cholesterol Education Program - Adult Treatment Panel III/America Heart Association/ National Heart, Lung and Blood (2005 NCEP-ATP III/AHA/ NHLB) criteria. Metabolic syndrome is common among Filipinos, with low HDL-cholesterol as the most prevalent component. MS predisposes to diabetes and stroke, with a tendency to myocardial infarction, which poses as an important health issue for the general population. According to the 2003 NNHES among 4753 individuals with MS using NCEP-ATP III criteria, the mean waist

In the last decade, there has been a dramatic increase in the incidence of metabolic syndrome globally, particularly in the Asia-Oceania region. Metabolic syndrome (MS) is a clustering of several metabolic risk factors that increases the risk of cardiovascular disease (CVD) and diabetes

Section of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of the Philippines – Philippine General Hospital

Reprint request to: Dr. Michelle V. Lemoncito, Section of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of the Philippines, Philippine General Hospital, Contact nos: 5218450 (local 3230)/ 0917-6204073,

Volume 48 Number 3 Oct.-Dec., 2010

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Lemoncito MV, et al circumference (WC) was lower among males (mean 79.3 cm) and females (mean 76.8 cm) with a total mean WC of 78.1 cm compared to WC cut-offs set by the 2001 NCEP-ATP III guidelines (≥102 cm in men and ≥88 cm i n women) and the 2005 International Diabetes Federation (IDF) guidelines [≥90 cm (Asian men) and ≥80 cm (Asian women)] 4. Hence, using these cutoffs would result in the underestimation of the prevalence of MS, failure in the identification of individuals at risk for future cardiovascular disease and underscores the importance of accurate WC measurement. On the contrary, the cross-sectional study of Araneta et al 5 among Filipino and American women showed that while Filipino and American women did not differ in mean age, body mass index, percentage body fat or waist-hip ratios, Filipino women had larger WC (by 2cm, mean 87.1 ± 9.3 cm) and truncal fat. Compared with Caucasians, Filipino women had a higher prevalence of type 2 diabetes by oral glucose tolerance test criteria (36 vs. 9%) and MS (34 vs. 13%). While WC is being used widely as an index for visceral fat accumulation and purportedly the primary pathology responsible for the MS, its proposed cut-off value varies depending on the disparate diagnostic criteria used as well as on the gender, race and ethnic group being evaluated. Due to the strong association between MS and central obesity, it is clear that WC should be incorporated into the routine physical exam when assessing CVD and diabetes risk.8,9-12 However, currently there is no standard location for the measurement of WC. According to the Anthropometric Standardization Reference Manual, WC should be measured at the narrowest point of the waist. 13 The World Health Organization guidelines and the 2005 international Diabetes Federation (IDF) recommend that WC be measured at the midpoint between the lowest rib and the iliac crest,4,10,14 whereas the National Institute of Health (NIH) recommends that WC be measured immediately above the iliac crest.10 Other studies have measured WC at the level of the umbilicus.15,16 Interestingly, the third report of the NCEP gives specific WC cut-off values for women and men but does not indicate whether this is for minimal waist, umbilical waist, or some other waist measure. 2 On review of the literature, we found no scientific rationale for preferring any one WC site to the others, thus this study. As a preliminary step toward standardizing WC measures, the present study will measure waist circumference measurement variation at three levels: (A) umbilical level, (B) midline level (between the inferior margin of the ribs and the superior border of the iliac crest) and (C) level of the superior border of the iliac crest among patients diagnosed with metabolic syndrome as defined by the 2005 NCEP-ATP III/AHA/NHLB criteria.

Significance of the Study

Due to the absence of a standard location for the

8


Impact of Waist Circumference Measurement Variation measurement of WC, the present study will determine the waist circumference measurement variations among patients with MS, as defined by the 2005 NCEP-ATP III/ AHA/NHLB criteria, at three levels: (A) umbilical level, (B) midline level (between the inferior margin of the ribs and the superior border of the iliac crest) and (C) level of the superior border of the iliac crest. 18

Objectives To determine waist circumference measurement variations among metabolic syndrome patients, as defined by the 2005 NCEP-ATP III/AHA/NHLB criteria, at three levels: (A) umbilical level, (B) midline level (between the inferior margin of the ribs and the superior border of the iliac crest) and (C) level of the superior border of the iliac crest. 18

M ethodology This is a cross-sectional analytical study. Adult patients, between 40 to 69 years of age, diagnosed with MS using 2005 NCEP-ATP III/AHA/NHLB criteria seen at the General Medicine and Endocrine OutPatient Clinics of the Philippine General Hospital were recruited in the study. This study is part of the Asia-Oceania Survey on the Metabolic Syndrome and Diabetes initiated by the Japan Diabetes Society. 18 Inclusion Criteria 1. M ales and females between 40 to 69 years old and willing to give informed consent; 2. M eet the criteria for metabolic syndrome as defined by the 2005 NCEP-ATP III/AHA/NHLB diagnostic criteria defined as any three of the following five criteria: (i) Waist circumference: Europe/North America: ≥94 cm (men) or ≥88 cm (women) Chinese/Southeast Asians/South Asians: ≥90cm (men) or ≥80cm (women) Japanese: ≥90cm (men) or ≥80cm (women) (ii) Fasting plasma glucose (FPG) levels ≥ 100mg/dL or on treatment (iii) Triglyceride levels ≥ 150 mg/dL or on treatment (iv) High density lipoprotein-cholesterol < 40 mg/dL (male) or < 50 mg/dL (female) or on treatment (v) Systolic blood pressure ≥ 130 or diastolic blood pressure ≥85 mmHg or on treatment. Exclusion Criteria 1. P regnant patients; 2. T ype 1 diabetes mellitus patients; 3. P atients presently on weight-reducing pharmacologic therapy; and 4. Other insulin-resistant states (Polycystic Ovary Syndrome (PCOS), Cushing’s syndrome).

Impact of Waist Circumference Measurement Variation Sample Size Based on the study of Sone et al 6 on 347 male patients with a mean waist circumference of 87.0 ± 6.5 and 248 female patients with a mean waist circumference of 80.4 ± 10.4 diagnosed with MS as defined by NCEP criteria, a total of 56 subjects (28 males and 28 females) were needed in this study. Sample Size Calculation nm=nf= (σ 12 + σ 22) [Zα + Zβ] 2 where: α = 0.05, β = 0.2 (X1 - X2) 2 =(42.25 + 108.16) [1.96 + 0.84] 2 (87 - 80.4)2 =1179.2144 = 28 (28 males and 28 females, total = 56 subjects) 43.56

D ata Collection Demographic data, including age, gender, height, body weight, body mass index, waist circumference (measured in the upright position), previous history of diabetes, dyslipidemia and hypertension and use of pharmacologic therapy (anti-diabetic/lipid-lowering/antihypertensive drugs) were obtained and recorded in a uniform datasheet (Appendix A). Height (cm) and weight (kg) was measured with the subjects wearing lightweight clothing (standard patient’s gown) but no shoes. Waist circumference (WC) was measured with a heavy-duty inelastic fiberglass tape that was calibrated against a metal tape measure to ensure accuracy. Subjects were instructed to stand with legs parallel and shoulder-width apart. WC was measured at the end of at minimal respiration, and rounded off to the nearest 0.1 cm. Circumferences were taken with the tape placed directly on the skin (not over clothing). WC was measured at three levels: (A) umbilical level, (B) midline level (between the inferior margin of the ribs and the superior border of the iliac crest), or (C) level of the superior border of the iliac crest (Figure 1). Each measurement was done once at each waist location before a second measurement is done. A third measurement was performed if the first two attempts were 0.7 cm apart. The most recent (past three months) fasting plasma glucose (FPG), fasting plasma triglycerides, fasting total cholesterol, fasting high density lipoprotein-cholesterol (LDL-C) was obtained from the patient’s medical records. Two blood pressure readings were measured with the patient in the sitting position using a mercury sphygmomanometer.

Ethical Consideration The study was conducted in accordance with the Declaration of Helsinki for biomedical research involving human subjects. In obtaining and documenting informed consent, the investigator complied with the applicable regulatory requirement(s) and adhered to International Conference on Harmonization (ICH) guideline for Good

Lemoncito MV, et al

the inferior margin of the ribs midline level umbilical level the superior border of the iliac crest

B A C

Figure 1. Measurement of waist circumference at three levels. (A) umbilical level, (B) midline level (between the inferior margin of the ribs and the superior border of the iliac crest), or (C) level of the superior border of the iliac crest. Waist circumference is measured with the subject standing, at minimal respiration, and rounded off to the nearest 0.1 cm.

Clinical Practice (GCP) and the requirements in the Declaration of Helsinki. Prior to the study, the investigator gave the subject (and/or the subject’s legally acceptable representative, if applicable) oral and written information about the trial in a form that the subject could read and understand. A voluntary, signed and dated Informed Consent Form (Appendix B, C) was obtained from the subject prior to the study. The written informed consent was signed and dated by the person who conducted the informed consent procedure. In conducting the study, all information obtained from the subjects was held confidential. The study did not allow particular individuals to be identified to safeguard personal information by ensuring that all personally identifiable information (i.e., ID number, medical record number, name or address) was excluded. The protocol was submitted for review by the Ethics Review Board of the institution and ethics approval from the Research Institute and Development Office (RIDO) was sought before the study was initiated.

Statistical Analysis Demographic data will be reported as means and percentages (Table 1). All study subjects were stratified by age (40 to 54/55 to 69 years of age) and gender (male/ female). The Student’s t test for continuous variables for waist circumference taken at three different levels was measured among patients. Data was analyzed using SPSS Version 17.

R esults

I. Demographic characteristics of study patients A total of 187 individuals were recruited and included in the study, 56 percent of whom were females. The mean age of the study subjects was 52.84 ± 7.76 years for men


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Impact of Waist Circumference Measurement Variation

Lemoncito MV, et al and 55.69 ± 7.47 for females. One hundred eighty patients (92%) had MS as defined by the 2005 NCEP-ATP III/AHA/ NHLB diagnostic criteria. Both males and females were obese stage 1 as defined Asia-Pacific Guidelines, 25.6 kg/ m2 and 26.6 kg/m2 respectively, which was statistically significant. The mean WC measurements at level A was 92.9 cm (81.36 – 104.44 cm) in men and 93.83 cm (83.4 – 104.26 cm) in women; at level B, the mean WC was 90.73 cm (75.49 –

Table I. Demographic Characteristics of Study Subjects, Grouped by Sex Men (n=81, 44%)

Women (n=106, 56%)

p

Mean age, years

52.84 (7.76)

55.69 (7.47)

0.601

Weight (kg)

70.36 (11.88)

62.51 (12.41)

0.434

Height (cm)

165.73 (6.32)

153.37 (8.55)

0.225

Body mass index (kg/m2)

25.6 (3.96)

26.6 (5.20)

0.035

Waist circumference (cm) (umbilical level: A)

92.9 (11.54)

93.83 (10.43)

0.901

Waist circumference (cm) (midline level: B)

90.73 (15.24)

91.51 (10.89)

0.419

Waist circumference (cm) (superior border of the iliac crest: C)

93.50 (11.53)

95.12 (10.01)

0.887

Fasting plasma glucose (mg/dl)

135.98 (69.72)

133.25 (57.95)

0.462

Fasting triglyceride (mg/dl)

130.40 (55.47)

149.54 (64.55)

0.14

Fasting total cholesterol (mg/dl)

186.55 (46.36)

199.72 (55.12)

0.486

Fasting HDL-cholesterol (mg/dl)

45.49 (20.16)

49.66 (38.03)

0.101

Systolic blood pressure (mmHg)

127.90 (15.55)

127.69 (18.22)

0.931

Diastolic blood pressure (mmHg)

82.16 (10.53)

78.24 (9.05)

0.019

Previously diagnosed diabetes (n, %)

79 (97)

105 (99)

-

Previously diagnosed dyslipidemia (n, %)

52 (64)

98 (92)

-

Previously diagnosed hypertension (n, %)

52 (64)

95 (89)

-

Anti-diabetic drug (n, %)

79 (97)

105 (99)

-

Lipid lowering drug (n, %)

55 (67)

97 (91.5)

-

2 (3.6)

3 (3.09)

-

Eicosapentaenoic acid

-

-

-

Nicotinic acid

-

-

-

Statins alone

Fibrates alone

52 (94.5)

87 (89.6)

-

Statin + Fibrate

1 (1.8)

7 (7.21)

-

Anti-hypertensive drug (n, %)

57 (70)

95 (89.6)

-

105.97 cm) in men and 91.51 cm (80.62 – 102.4 cm) in women, and at level C, the mean WC was 93.5 cm (81.97 – 105.03 cm) in men and 95.12 cm (85.11 – 105.13 cm) in women. There was no significant difference in the mean WC at three levels between genders. There was no significant difference between genders in terms of fasting glucose, fasting triglyceride, fasting cholesterol, fasting HDL-cholesterol, LDL-cholesterol and systolic blood pressure. There was significant difference in diastolic blood pressure between men and women (P = 0.019). There were more diagnosed diabetic women (99%) compared to men (92%) and more dyslipidemic and hypertensive women compared to men (91% vs. 59% and 88% vs. 59% respectively). Almost all, men and women, were treated with anti-diabetic drugs. More women were on anti-lipid and anti-hypertensive drugs as compared to men (89% vs. 63% and 87% vs. 64% respectively). Majority were taking statins as an anti-lipid therapy (60% in men, 80% in women).

Table II. Mean Waist Circumference (cm) Measurements at Three Levels among all Patients with Metabolic Syndrome Metabolic Syndrome (including waist circumference) (n = 187) Level A

93.42 (10.90)

Level B

91.18 (12.92)*

Level C Mean ± SD

Table III. Mean Waist Circumference Measurements at Three Levels, according to Sex Waist circumference (cm)/sex

Male (n = 81)

Female (n = 106)

P

Level A

92.9 (11.54)

93.83 (10.43)

0.901

Level B

90.73 (15.24)

91.51 (10.89)

0.419

Level C

93.50 (11.53)

95.12 (10.01)

0.887

Mean ± SD

Table IV. Mean Waist Circumference Measurements at Three Levels, according to Age Waist Circumference (cm)/Age (y)

40-54 y (n = 87)

55-69 y (n = 100)

P

Level A

92.81 (9.36)

93.96 (12.11)

0.138

Level B

91.59 (10.50)

90.83 (14.75)

0.214

Level C

94.12 (9.83)

94.68 (11.44)

0.720

Mean ± SD

10


94.42 (10.70)* *Sig 0.22


Lemoncito MV, et al

Among 187 individuals diagnosed with MS as defined by the 2005 NCEP-ATP III/AHA/NHLB diagnostic criteria, results showed that there was greater variability between WC measurements at level B and C (p= 0.007). There was no significant difference in mean WC measurements taken at three levels among patients with MS when stratified according to sex. There was no significant difference in mean WC measurements taken at three levels among patients with MS when stratified according to age.

AHA/NHLB criteria, WC at level B (midpoint level between the lower ribs and superior border of the iliac crest) was smaller than waist circumference at level A (umbilical level) and smaller than level C (superior border of the iliac crest) (WCB < WCA < WCC). There was greater variability in mean waist circumference measurements at level B and level C consistent with other foreign literature. Mean WC measurements at level A and level B were similar and less variable and is a more accurate measurement compared to level C.

D iscussion

R ecommendations

The mean WC measurement at the three levels in the present study was higher compared to the mean WC of 78.1 cm among all Filipino patients with MS reported in the 2004 NNHES Survey. Compared to Asian data, the mean WC in the present study was higher compared to the study of Sone et al 6 which reported a mean WC of 87 cm among Japanese men and 80.4 cm among Japanese women with NCEP-defined MS. This can probably be explained by having more obese patients in the present study compared to overweight patients (mean BMI = 24.4 kg/m2) as reported in the latter. Similarly, the mean WC measurements were higher compared to cutoff levels of 85 cm for men and 78 cm for women yielding the maximal sensitivity and specificity for predicting multiple risk factors set by Hara K et al.17 Results showed that WC measurements at three levels did not statistically differ when patients were stratified into age and sex. However, when WC was measured among all patients with MS, regardless of age and sex, there was significant difference in WC at level B and level C (Sig = 0.022). Waist circumference measured at level A was similar and less variable to WC measured at level B, the currently recommended WC measurement as defined by the 2005 IDF diagnostic criteria. The present study showed that the mean WC at level B was smaller than WC at level A and smaller than WC at level C, with greater variability in WC measurements taken at level B and level C. This was consistent with the study of Wang et al when he compared WC values at four commonly used anatomic sites: immediately below the lowest ribs (WC1), the narrowest waist (WC2), the midpoint between the lowest rib and the iliac crest (WC3), and immediately above the iliac crest (WC4). He reported that among men, the mean of WC2 was significantly smaller than the means at the other three sites, which did not differ significantly from each other. Among females, the mean for each site was significantly different from the other means, with WC2 < WC1 < WC3 < WC4. Age did not influence the differences between WC sites in either males or females.

Due to the strong association between MS and central obesity, WC should be incorporated into the routine physical exam when assessing CVD and diabetes risk and can allow clinicians to monitor changes in visceral adipose tissue over time. Mean WC measurements at level A and level B were similar and less variable and may be a better WC measurements to level.

C onclusion

Among patients with MS as defined by NCEP-ATP III/

R eferences 1. Dantes D Morales, Felix Eduardo R Punzalan, Elizabeth PazPacheco, Rody G Sy, Charmaine A Duante: Metabolic Syndrome in the Philippine General Population: Prevalence and Risk for Atherosclerotic Cardiovascular Disease and Diabetes Mellitus (2003 NNHES Survey), Diabetes Vascular Disease Research, 2008:5:36-43. 2. National Cholesterol Education Program Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (ATP III): Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002;106:3143-421. 3. National Institutes of Health: Executive summary: In Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Washington, DC, U.S. Govt. printing Office, 2001 (NIH publ. no. 01-3670). 4. Ford E: Prevalence of the Metabolic Syndrome Defined by the International Diabetes Federation Among Adults in the U.S. Diabetes Care, Volume 28: number 11, November 2005 5. Araneta MR, Wingard DL, Barrett-Connor E: Type 2 Diabetes and Metabolic Syndrome in Filipina-American Women, Diabetes Care, Volume 25, Number 3, March 2002. 6. Sone H, Mizuno S et al: Is the Diagnosis of Metabolic Syndrome Useful for Predicting Cardiovascular Disease in Asian Diabetic Patients? Diabetes Care, Volume 28:1463-1471, 2005. 7. Lorenzo C, Serrano-Rios M et al: Is Waist Circumference an Essential Component of the Metabolic Syndrome? Diabetes Care, Volume 30, Number 8, August 2007. 8. Wang J: Waist circumference: a simple, inexpensive, and reliable tool that should be included as part of physical examinations in the doctor’s office. Am J Clin Nutr. 2003;78:902–3. 9. Pi-Sunyer FX: Obesity: criteria and classification. Proc NutrSoc. 2000;59:505–9. 10. Wang J, Thornton JC, Bari S, et al: Comparisons of waist circumferences measured at 4 sites. Am J Clin Nutr. 2003;77:379– 84. 11. Pouliot MC, Despres JP, Lemieux S, et al: Waist circumference and abdominal sagittal diameter: best simple anthropometric


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12.

13. 14. 15.

16. 17.

18.

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indexes of abdominal visceral adipose tissue accumulation and related cardiovascular risk in men and women. Am J Cardiol. 1994;73:460–8. Dobbelsteyn CJ, Joffres MR, MacLean DR, Flowerdew G: A comparative evaluation of waist circumference, waist-to-hip ratio and body mass index as indicators of cardiovascular risk factors: The Canadian Heart Health Surveys. Int J Obes Relat Metab Disord. 2001;25:652– 61. Lohman T: Anthropometric Standardization Reference Manual. Champaign, IL: Human Kinetics; 1988. Ford ES, Giles WH: A comparison of the prevalence of the metabolic syndrome using two proposed definitions. DiabetesCare. 2003;26:575– 81. Grinker JA, Tucker KL, Vokonas PS, Rush D: Changes in patterns of fatness in adult men in relation to serum indices of cardiovascular risk: the Normative Aging Study. Int J Obes Relat Metab Disord. 2000;24:1369 –78. Rexrode KM, Carey VJ, Hennekens CH, et al: Abdominal adiposity and coronary heart disease in women. JAMA. 1998; 280:1843– 8. Hara K, Matsushita Y et al: A proposal for the cutoff point of waist circumference for the diagnosis of metabolic syndrome in the Japanese population, Diabetes Care, volume 29, number 5, May 2006.. An International Survey on the Metabolic Syndrome and Diabetes in Japan as Part of Asia and Oceania, Japan Diabetes Society (unpublished)..




Lemoncito MV, et al

A ppendix A (Data Sheet) Age

years of age

Sex

male/female

Height

cm

Body weight

kg

Waist circumference (umbilical level: A)

cm

Waist circumference (midline level: B)

cm

Waist circumference (superior border of the iliac crest: C)

cm

Fasting plasma glucose

mg/dL

Fasting triglyceride

mg/dL

Fasting total cholesterol

mg/dL

Fasting HDL-cholesterol

mg/dL

Systolic blood pressure

mmHg

Diastolic blood pressure

mmHg PAST MEDICAL HISTORY

Previously diagnosed diabetes

YES/NO/UNKNOWN

Previously diagnosed dyslipidemia

YES/NO/UNKNOWN

Previously diagnosed hypertension

YES/NO/UNKNOWN PHARMACOLOGICAL THERAPY

Anti-diabetic drug

YES/NO/UNKNOWN

Lipid lowering drug

YES/NO/UNKNOWN

Fibrates

YES/NO/UNKNOWN

Eicosapentaenoic acid

YES/NO/UNKNOWN

Nicotinic acid

YES/NO/UNKNOWN

Statins

YES/NO/UNKNOWN

Other lipid –lowering drug

92.81 (9.36)

Anti-hypertensive drug

YES/NO/UNKNOWN

A ppendix B (Patient’s Informed Consent) I, (Name)

, (Age)

, (Gender) , residing at (Address) , give my consent to participate in the study entitled “Impact of Waist Circumference Measurement Variation on the Diagnosis of Metabolic Syndrome.” under the supervision of Dr. Michelle V. Lemoncito (Principal Investigator), Dr. Elizabeth PazPacheco (Co-Investigator), and Dr. Mary Anne Lim-Abrahan (Co-Investigator). 1. I have read and understood and been given sufficient time to think about the Study Information for the Patient and agree to join this study. 2. I have been given adequate explanation regarding the objectives of this study and measurements to be done and what will be required of me. 3. I understand that I am free to leave the study at anytime, and that this will not in any way affect the medical care I am receiving currently or in the future. 4. I understand that the results of this study may be published, but that my identity will remain


13


Lemoncito MV, et al

5. I give consent for the regulatory authorities, Ethics committee and the principal study investigators to have direct access to my medical records. 6. I agree that the study physician will inform my primary physician of my participation in this study.

Name of patient

Signature

Date

Name of person who got the Informed Consent

Signature

Date

A ppendix C (Study Information for the Patient) This study is entitled: “Impact of Waist Circumference Measurement Variation of the Diagnosis of Metabolic Syndrome.”

Read this carefully before agreeing to join this study.

This contains details regarding the examinations and measurements to be carried out in this study. The physician in charge of this study will discuss this written information with you, and will answer any of your questions regarding the study. After you have read and fully understood what will be required and you wish to join the study, you will be asked to sign an Informed Consent form. Read the Informed Consent form carefully before signing. You will be given a copy of the “Study Information for the Patient” and “Informed Consent”. Information about the Study The first objective of this study is to (1) determine waist circumference measurement variations among metabolic syndrome patients, as defined by the 2005 NCEP-ATP III/ AHA/NHLB criteria, at three levels: (A) umbilical level, (B) midline level (between the inferior margin of the ribs and the superior border of the iliac crest) and (C) level of the superior border of the iliac crest. Secondly, it will compare waist circumference measurements taken at three levels in the diagnosis of metabolic syndrome. Thirdly, this study will determine whether waist circumferences measured at level A and level C can be

14


used as alternative measurements to waist circumference measured at level B, which is the recommended waist circumference measurement (2005 IDF diagnostic criteria for metabolic syndrome). Previous studies in the Philippines have shown that the prevalence of metabolic syndrome is 11.9% by National Cholesterol/Adult Treatment Panel III (NCEP/ATP III) criteria, 14.5% by International Diabetes Federation (IDF) criteria and 18.6% by NCEP-ATP III/AHA/NHLB criteria. Qualifications to Participate All males and females between 40 to 69 years old, willing to give informed consent who meet the criteria for metabolic syndrome as defined by the 2005 National Cholesterol Education Program - Adult Treatment Panel III/ America Heart Association/National Heart, Lung and Blood (2005 NCEP-ATP III/AHA/NHLB) criteria excluding waist circumference shall be eligible to participate. Study Procedures The study will require the investigator to collect data on the following data and anthropometric measurements: age (years), gender (male/female), height (cm), body weight (kg), 2 recorded measurements of blood pressure (in sitting position) and waist circumference (cm) measured at 3 levels: (A) umbilical level, (B) midline level (between the inferior margin of the ribs and the superior border of the iliac crest), or (C) level of the superior border of the iliac crest. Height (cm) and weight (kg) shall be measured with the subjects wearing lightweight clothing but not shoes. Waist circumference is measured with the subject standing, at minimal respiration, and rounded off to the nearest 0.1 cm. Your most recent (last 3 months) fasting plasma glucose (FPG), fasting plasma triglycerides, fasting total cholesterol, fasting HDL-cholesterol will obtained from your medical charts. History of diabetes, dyslipidemia and hypertension and the use of pharmacological therapy (use of anti-diabetic/ lipid-lowering/antihypertensive drugs) shall be obtained


Lemoncito MV, et al

single visit to collect the necessary data as mentioned above. Participation in the Study Your participation in this study is purely voluntary. You may refuse to take part in the study or may stop your participation at any time. Should you wish not to join, you will not be asked to explain. The physician in charge of the study will not be angered and your care at the present and in the future will not be compromised. Should you join the study and then change your mind, you are free to leave at any time and this will not affect your medical care in any way. In signing the Informed Consent form, you are agreeing to join the study and to follow the instructions to be given during the study period. Possible Benefits Your valuable participation in this study and the information obtained through this research will contribute to the medical knowledge on the importance of accurate waist circumference measurement in the diagnosis of metabolic syndrome. This study will provide us preliminary data on waist circumference measurements taken at the umbilical level, midline level, and superior border of the iliac

crest among Filipino patients seen at the Philippine General Hospital. Should you are diagnosed to have diabetes, high blood cholesterol levels or hypertension, you will be referred to dietary service and specialists who can help you. Confidentiality All personal information will be handled in a confidential manner. All information gathered for this study is strictly confidential. When data gathered in this study are published, you will not be identified in any published report. The investigating physicians and Ethics committee may review your medical records. Participants will be free to withdraw from the study anytime. However, he/she may still receive a copy of the results if he/she s requests. Contact Person: If you have further questions regarding this study, you may contact: Name: Dr. Michelle V. Lemoncito Address: Section of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of the Philippines, Philippine General Hospital Telephone no: 5218450 (local 3230)/ 0917-6204073

Katibayan ng Pagsang-ayon ng Pasyente Ako, si (Pangalan)

, (Edad)

, (Kasarian) , naninirahan sa (Tirahan) , ay sumasang-ayon na lumahok sa pananaliksik na pinamagatang “Impact of Waist Circumference Measurement Variation of the Diagnosis of Metabolic Syndrome” sa pamamahala ni Dr. Elizabeth Paz-Pacheco (Principal-Investigator), Dr. Mary Anne Lim-Abrahan (Principal-Investigator) at Dr. Michelle V. Lemoncito (Co-Investigator). Ang mga sumusunod ay ipinaliwanag nang mabuti sa akin at lubos ang aking pangunawa sa mga ito bago ko nilagdaan ang kasulatang ito. 1. Aking nabasa at naintindihan at nabigyan ng sapat na panahon upang pag-isipan ang Kaalaman ukol sa Pananaliksik para sa Pasyente at sumasang-ayong makilahok sa pananaliksik na ito. 2. Ako ay nabigyan ng sapat na paliwanag tungkol sa layunin ng pananaliksik, sa mga eksaminasyon at pagsusukat na kasali, at kung ano ang hihilingin sa akin. 3. Aking naunawaan na ako ay lubusang malayang umalis sa pananaliksik sa anumang oras, at ang aking pag-alis ay hindi, sa anumang paraan, makakaapekto sa aking panggagamot sa hinaharap o medikal na pangangalaga. 4. Aking nauunawaan na ang mga resulta ng pananaliksik na ito ay maaaring mailahatla, ngunit ang aking pagkakakilanlan ay mananatiling lihim. 5. Binibigyan ko ng pahintulot ang mga awtoridad sa regulatoryo, “Ethics committee” at ang mga namumuno sa pananaliksik na magkaroon ng tuwirang “access” sa aking mga medikal na talaan.


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Lemoncito MV, et al

6. Ako ay sumasang-ayon na ipaalam ng doktor sa pananaliksik sa aking pangunahing doktor ang aking paglahok sa pananaliksik na ito.

Pangalan ng pasyente

Lagda

Petsa

Pangalan ng taong nagsagawa ng pagkuha ng katibayan ng Pag-sang-ayon

Lagda

Petsa

Katibayan ng Pagsang-ayon ng Pasyente Ang Pag-aaral ay tungkol sa: “Impact of Waist Circumference Measurement Variation of the Diagnosis of Metabolic Syndrome.” aaral.

Basahin at unawain ng mabuti bago sumali sa pag-

Ito ay naglalaman ng detalye tungkol sa pagsusuri at pagsusukat na kakailangin sa pag-aaral. Ang doktor na humahawak sa pag-aaral ay makipagusap sa iyo tungkol sa mga nakasaad na impormasyon sa kasulatan at sasagutin niya kung may nais kang lilinawin tungkol sa pag-aaral. Kapag nabasa mo na at naunawaan ng mabuti ang kasulatan at nag desisyon kang sumali sa pag-aaral kailangan kang pumirma sa Kasulatan ng Pahintulot. Basahin at unawain ng mabuti ang kasulatan bago ka pumirma. Bibigyan ka ng kopya “Kaalaman Ukol sa Pananaliksik Para sa Pasyente” at “Katibayan ng Pagsangayon ng Pasyente”. Impormasyon Tungkol sa Pag-aaral Ang unang layunin ng pag-aaral na ito ay para malaman ang sukat ng baywang na susukatin sa tatlong pantay: (A) sa “level” ng pusod, (B) “midline level” na nasa gitna ng pinakahuling tadyang at ng “superior border ng iliac crest”, at (C) sa “level” ng “superior border of the iliac crest.” Pangalawang layunin, ipaghahambingin ang sukat ng baywang nakuha sa tatlong pantay sa pagkilala ng “metabolic syndrome” sa paggamit ng “2005 NCEP-ATP III/ AHA/NHLB criteria”. Pangatlo, ang pag-aaral na ito ay para malaman kung yung sukat ng baywang sa Level A at Level B ay maaring gamiting “alternative” sukat ng baywang sa Level

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B, “recommended waist circumference measurement” ng “2005 IDF diagnostic criteria for metabolic syndrome”. Sa mga nakaraang pag-aaral dito sa ating bansa ang Pilipinas ay ipinakita na labing-isa porsyento ay may “metabolic syndrome” kung gagamitin ang “National Cholesterol/Adult Treatment Panel III (NCEP/ATP III) criteria” at labing-apat na porsyento ay may “metabolic syndrome” kung gagamitin ang “International Diabetes Federation (IDF) criteria”. Katangian Para Makilahok: Lahat ng kalalakihan at kababaihan sa pagitan ng 40-69 taong gulang, handang magbigay ng pahintulot sa pag-aaral at makapasa sa “criteria for metabolic syndrome” ng “2005 National Cholesterol Education Program - Adult Treatment Panel III/America Heart Association/National Heart, Lung and Blood (2005 NCEP-ATP III/AHA/NHLB) criteria” ay karapat-dapat na lumahok sa pag-aaral na ito. Paraan ng Pag-aaral: Sa pag-aaral na ito hihilingin sa “investigator” na maglikum ng mga data sa mga sumusunod na “data” at “anthropometric measurements”: edad (taon), kasarian (lalaki/babae), taas (cm), timbang (kg), dalawang talaan ng blood pressure (nakaupo) at waist circumference (cm) nasukat sa tatlong pantay: (A) sa “level” ng pusod, (B) “midline level” na nasa gitna ng pinakahuling tadyang at ng “superior border ng iliac crest”, at (C) sa “level” ng “superior border of the iliac crest.” Ang sukat ng baywang ay sinusukat kasama ang paksa/pasyente ng nakatayo, at “minimal respiration”, at “rounded off to the nearest 0.1 cm”. Taas (cm) at timbang (kg) ay isusukat kasama ang paksa/ pasyente gumamit ng magaang kasuotan at walang suot na sapatos. Ang pinaka-kasalukuyang (huling 3 buwan) “fasting plasma glucose” (FPG), “fasting plasma triglycerides”, “fasting total cholesterol”, “fasting HDL-cholesterol” na makukuha mula sa iyong medikal na talaan. Kasaysayan ng diabetes, dyslipidemia at hypertension at


Lemoncito MV, et al

ang paggamit ng pharmacological therapy (pag-gamit ng gamot para anti-diabetic/lipid-lowering/antihypertensive) ay kukuhanin sa medikal na talaan ng pasyente. Walang laboratoryo o gamut i-bibigay patiente sa itong pag-aaral. Kung ikaw ay nakikitaan na may “diabetes” (mataas na asukal), “high blood cholesterol levels” (mataas na cholesterol) or “hypertension” (altapresyon), irerekomenda ka sa doktor na makakatulong sa iyong sakit. Tagal ng Pag-aaral Ang tagal ng pagsali mo sa pag-aaral ay isang pagbisita lamang para malikom ang mga kakailanganing impormasyon na nakasaad sa taas. Paglahok sa Pag-aaral Ang pakikilahok mo sa pag-aaral ay kusang-loob. Maari kang tumanggi na maging bahagi sa pag-aaral o malaya kang makaalis anumang oras na walang ibibigay na dahilan. Ang doktor na humahawak sa pag-aaral ay unawain ang iyong naging pasiya at hindi maapektuhan ang pangangalagang medikal na tinatanggap mo sa kasalukuyan at sa darating pa na panahon. Sa pagpirma mo sa Katibayan ng Pagsang-ayon ng Pasyente, ikaw ay sumasangayon na lumahok at susundin ang lahat ng ituturo sa panahon ng pag-aaral. Maaring Kapakinabangan: Ang paglahok mo sa pag-aaral at ang mga impormasyong nakuha sa pagsisiyasat na ito ay makaambag sa medikal na kaalaman sa kahalagahan ng “waist circumference measurement in the diagnosis of metabolic syndrome”. Ang pag-aaral na ito ay magbibigay sa atin ng “preliminary data on waist circumference measurements taken at the umbilical level, midline level, and superior border of the iliac crest among Filipino patients seen at the Philippine General Hospital”. Kung ikaw ay makikitaan na may “diabetes” (mataas na asukal), “high blood cholesterol levels” (mataas na cholesterol) or “hypertension” (altapresyon), irerekomenda ka sa doktor na maaring makatulong sa iyong sakit. Paglilihim: Lahat ng impormasyon na natipon sa pag-aaral na ito ay magiging lihim. Kapag ang mga nalikom, na impormasyon sa pag-aaral ay mailalatha iingatan namin ang inyong karapatan sa paglilihim. Ang mga doctor at “Ethics Committee” ay maaring repasuhin ang inyong medikal na talaan. Ang mga lumalahok ay malayang makakaalis sa pag-aaral anumang oras. Gayon man, sya ay makakatanggap ng kopya ng resulta kung ito ay kanyang hilingin. Contact Person: Kung may karagdagang katanungan tungkol sa pag-aaral na ito maaring tawagan o puntahan: Pangalan: Dr. Michelle V. Lemoncito Address: Section of Endocrinology, Diabetes & Metabolism,


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