- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02958579
a Population Based Study on Metabolic Syndrome Complications, and Mortality (MetSCoM)
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;
- 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.
- 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.
- To find the effect of behavioral variables and environmental exposures on the course of metabolic syndrome.
- To identify the best anthropometric, laboratory, life-style and environmental predictors of CVD and mortality rate in subjects with metabolic syndrome.
- To estimate the economic burden of metabolic syndrome and its related
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alireza Esteghamati, MD
- Email: esteghamati@tums.ac.ir
Study Contact Backup
- Name: Zahra Aryan, MD, MPH
- Email: aryanzahra@yahoo.com
Study Locations
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Tehran, Iran, Islamic Republic of, 13145-784
- Recruiting
- Tehran University of Medical Sciences
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Contact:
- Zahra Aryan, MD, MPH
- Email: aryanzahra@yahoo.com
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Contact:
- Alireza Esteghamati, M.D.
- Email: esteghamati@tums.ac.ir
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Principal Investigator:
- Mohsen Afarideh, M.D.
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Principal Investigator:
- Alireza Ghajar, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Obesity
Body mass index (BMI) score > 25.2 kg/m2 for women and > 27.3 kg/m2 for men or Waist circumference > 90 cm
|
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Pre-diabetics or diabetics
if any of followings is identified the participant is regarded as diabetics and will be recruited in this arm;
1- FPG levels of 100-125 mg/dl (5.6-6.9 mmol/l). 2-Two-h plasma glucose (2HPP) in the 75 g oral glucose tolerance test of 140-199 mg/dl (7.8- 11.0 mmol/l) |
|
Hypertension
Systolic blood pressure (SBP) ≥ 130mmHgand/or diastolic blood pressure (DBP) ≥ 85mmHg or use of anti-hypertensive drugs
|
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hypertriglyceridemia
Serum triglyceride ≥150 mg/dL
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Low high density lipoprotein -cholesterol (HDL-c)
Serum HDL-C of <40 mg/dL for men, <50 mg/dL for women,
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of CVD
Time Frame: 10 years
|
10 years
|
incidence of microvascular complications of T2D (diabetic retinopathy, diabetic neuropathy, diabetic kidney disease), and diabetic foot
Time Frame: 10 years
|
10 years
|
incidence of non-alcoholic fatty liver disease (NAFLD)
Time Frame: 10 years
|
10 years
|
incidence of colorectal, breast and cervical cancers
Time Frame: 10 years
|
10 years
|
mortality rate
Time Frame: 10 years
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
economic burden of metabolic syndrome
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mohsen Afarideh, MD, MPH, Tehran University of Medical Sciences
- Principal Investigator: Alireza Ghajar, MD, Tehran University of Medical Sciences
Publications and helpful links
General Publications
- 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.e5. doi: 10.1016/j.ahj.2015.06.017. Epub 2015 Jun 27.
- 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 Nov;254:42-51. doi: 10.1016/j.atherosclerosis.2016.09.009. Epub 2016 Sep 9.
- 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;244:165-71. doi: 10.1016/j.atherosclerosis.2015.11.020. Epub 2015 Nov 23.
- 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):e189. doi: 10.2337/dc16-1211. No abstract available.
- 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. 2017 Apr;43(2):180-183. doi: 10.1016/j.diabet.2016.07.032. Epub 2016 Sep 17. No abstract available.
- 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):55-61. doi: 10.1016/j.diabet.2015.10.001. Epub 2015 Oct 31.
- 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.2014.02.001. Epub 2014 Mar 14.
- 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 May-Jun;8(3):279-86. doi: 10.1016/j.jacl.2014.02.002. Epub 2014 Feb 15.
- 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.2013.0119. Epub 2014 Jan 21.
- Aryan Z, Ghajar A, Faghihi-Kashani S, Afarideh M, Nakhjavani M, Esteghamati A. Baseline High-Sensitivity C-Reactive Protein Predicts Macrovascular and Microvascular Complications of Type 2 Diabetes: A Population-Based Study. Ann Nutr Metab. 2018;72(4):287-295. doi: 10.1159/000488537. Epub 2018 Apr 25.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 95-03-191-33053
- 957275 (Other Grant/Funding Number: National Institute for Medical Research Development (NIMAD))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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