Metabolic Syndrome X Clinical Trial
— MetSCoMOfficial title:
A Population Based Cohort Study on Metabolic Syndrome Complications, and Mortality; (MetSCoM) Study
Metabolic syndrome (MetS) is recognized as clustering of a number of components including
hypertension, hypertriglyceridemia, low serum high-density lipoprotein cholesterol (HDL-C),
impaired glucose metabolism (IGM), and abdominal obesity. It has been tightly linked to
thrombotic vascular events including coronary heart disease (CHD). Worldwide prevalence of
MetS is on the rise. People living in Iran, a country located in the Middle-East region,
have distinct behavioral, environmental and social exposures which certainly affect the
prevalence and incidence of metabolic syndrome and its comorbidities.We hypothesized that
these factors may affect the course of metabolic syndrome and the burden that it imposes to
the community. The purposes of MetSCoM are as follows;
1. To find the incidence of T2D, microvascular complications of T2D (diabetic retinopathy,
diabetic neuropathy and diabetic kidney disease), CVD, and mortality rate of subjects
metabolic syndrome.
2. To find the association of baseline, mean value during follow up visits and visit to
visit variability in anthropometric variables and several metabolic laboratory
variables with metabolic syndrome and its complications.
3. To find the effect of behavioral variables and environmental exposures on the course of
metabolic syndrome.
4. To identify the best anthropometric, laboratory, life-style and environmental
predictors of CVD and mortality rate in subjects with metabolic syndrome.
5. To estimate the economic burden of metabolic syndrome and its related
Status | Recruiting |
Enrollment | 10000 |
Est. completion date | January 2020 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Obesity or central obesity, or - Diabetes (Fasting Plasma glucose (FPG) level = 7.0 mmol/l (126 mg/dL), or Plasma glucose = 11.1 mmol/l (200 mg/dL) two hours after a 75 g oral glucose load as in a glucose tolerance test, or Symptoms of hyperglycemia and casual plasma glucose = 11.1 mmol/l (200 mg/dL), or Glycated hemoglobin (A1C) = 6.5%), - pre-diabetes (FPG levels of 100-125 mg/dl (5.6-6.9 mmol/l), or 2-h plasma glucose (2HPP) in the 75 g oral glucose tolerance test of 140-199 mg/dl (7.8-11.0 mmol/l), or - Hypertension (Systolic blood pressure (SBP) = 130mmHgand/or diastolic blood pressure (DBP) = 85mmHg or use of anti-hypertensive drugs), or - Low HDL-c (Serum HDL-C of <40 mg/dL for men, <50 mg/dL for women,) - Hypertriglyceridemia, (TG>150 mg/dL) Exclusion Criteria: - type 1 diabetes - type 2 diabetes who required insulin therapy at baseline - gestational diabetes - Any malignancy, rheumatologic diseases, chronic kidney, lung or heart diseases at baseline at baseline - known hepatitis due to infectious and auto-immune diseases |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Tehran University of Medical Sciences | Tehran |
Lead Sponsor | Collaborator |
---|---|
Tehran University of Medical Sciences |
Iran, Islamic Republic of,
Afarideh M, Aryan Z, Ghajar A, Noshad S, Nakhjavani M, Baber U, Mechanick JI, Esteghamati A. Complex association of serum alanine aminotransferase with the risk of future cardiovascular disease in type 2 diabetes. Atherosclerosis. 2016 Sep 9;254:42-51. do — View Citation
Afarideh M, Noshad S, Ghajar A, Aryan Z, Khajeh E, Hosseini Shirvani S, Bonnet F, Esteghamati A. Family history of diabetes and the risk of coronary heart disease in people with or without type 2 diabetes. Diabetes Metab. 2016 Sep 16. pii: S1262-3636(16)3 — View Citation
Aryan Z, Noshad S, Afarideh M, Esteghamati A. Comment on Sharif et al. HDL Cholesterol as a Residual Risk Factor for Vascular Events and All-Cause Mortality in Patients With Type 2 Diabetes. Diabetes Care 2016;39:1424-1430. Diabetes Care. 2016 Oct;39(10): — View Citation
Esteghamati A, Hafezi-Nejad N, Sheikhbahaei S, Heidari B, Zandieh A, Ebadi M, Nakhjavani M. Risk of coronary heart disease associated with metabolic syndrome and its individual components in Iranian subjects: a matched cohort study. J Clin Lipidol. 2014 M — View Citation
Esteghamati A, Hafezi-Nejad N, Zandieh A, Sheikhbahaei S, Ebadi M, Nakhjavani M. Homocysteine and metabolic syndrome: from clustering to additional utility in prediction of coronary heart disease. J Cardiol. 2014 Oct;64(4):290-6. doi: 10.1016/j.jjcc.2014. — View Citation
Faghihi-Kashani S, Bonnet F, Hafezi-Nejad N, Heidari B, Aghajani Nargesi A, Sheikhbahaei S, Ebadi M, Esteghamati A. Fasting hyperinsulinaemia and 2-h glycaemia predict coronary heart disease in patients with type 2 diabetes. Diabetes Metab. 2016 Feb;42(1) — View Citation
Heidari B, Nargesi AA, Hafezi-Nejad N, Sheikhbahaei S, Pajouhi A, Nakhjavani M, Esteghamati A. Assessment of serum 25-hydroxy vitamin D improves coronary heart disease risk stratification in patients with type 2 diabetes. Am Heart J. 2015 Sep;170(3):573-9 — View Citation
Nargesi AA, Heidari B, Esteghamati S, Hafezi-Nejad N, Sheikhbahaei S, Pajouhi A, Nakhjavani M, Esteghamati A. Contribution of vitamin D deficiency to the risk of coronary heart disease in subjects with essential hypertension. Atherosclerosis. 2016 Jan;244 — View Citation
Sheikhbahaei S, Fotouhi A, Hafezi-Nejad N, Nakhjavani M, Esteghamati A. Serum uric acid, the metabolic syndrome, and the risk of chronic kidney disease in patients with type 2 diabetes. Metab Syndr Relat Disord. 2014 Mar;12(2):102-9. doi: 10.1089/met.2013 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of CVD | 10 years | No | |
Primary | incidence of microvascular complications of T2D (diabetic retinopathy, diabetic neuropathy, diabetic kidney disease), and diabetic foot | 10 years | No | |
Primary | incidence of non-alcoholic fatty liver disease (NAFLD) | 10 years | No | |
Primary | incidence of colorectal, breast and cervical cancers | 10 years | No | |
Primary | mortality rate | 10 years | Yes | |
Secondary | economic burden of metabolic syndrome | 10 years | No |
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