a Population Based Study on Metabolic Syndrome Complications, and Mortality

Metabolic Syndrome X Clinical Trial

— MetSCoM  

Official title:

A Population Based Cohort Study on Metabolic Syndrome Complications, and Mortality; (MetSCoM) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02958579
• Other study ID #: 95-03-191-33053
• Secondary ID: 957275
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2016
• Last updated: November 5, 2016
• Start date: January 2005
• Est. completion date: January 2020

Study information

• Verified date: November 2016
• Source: Tehran University of Medical Sciences
• Contact: Alireza Esteghamati, MD
• Email: esteghamati[@]tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Tehran University of Medical Sciences
• Study type: Observational

Clinical Trial Summary

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

Description:

A biphasic observational study will be conducted on participants with any component of metabolic syndrome in Tehran, Iran. Phase one of the study is a cross-sectional study, while the second phase is a prospective cohort. In phase one of study, the prevalence of any metabolic disorder will be estimated in the study population and the association of biochemical variables, behavioral and environmental variables with each metabolic disorder will be investigated. Afterwards, through the phase two, those with any component of metabolic syndrome will be followed to record the incidence of diabetes, vascular complications of diabetes, non-alcoholic fatty liver disease, (NAFLD), cancers, mortality rate and finally estimation of economic burden of metabolic syndrome and its components in study population. Participants will be recruited from four health surveillance centers located at East, West, North and South of Tehran, the capital city of Iran. The latitude of Tehran is 35°41' North, and 51°25' East. Participants will be followed for at least 10 years and we plan to extend this time if possible. Anthropometric, biochemical, behavioral and meteorological measurements will done on scheduled timeline.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (9)

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

Outcome

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