a Population Based Study on Metabolic Syndrome Complications, and Mortality (MetSCoM)

November 5, 2016 updated by: Tehran University of Medical Sciences

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

Study Overview

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All community dwellers aged greater than 40 years who are willing to participate will be included if met any of the following eligibility criteria; (1) central obesity, or (2) obesity, or (3) T2D or prediabetes, or (4) hypertension, or (5) hypertriglyceridemia, or (6) low high density lipoprotein-cholesterol (HDL-C).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obesity
Body mass index (BMI) score > 25.2 kg/m2 for women and > 27.3 kg/m2 for men or Waist circumference > 90 cm
Pre-diabetics or diabetics

if any of followings is identified the participant is regarded as diabetics and will be recruited in this arm;

  1. Fasting Plasma glucose (FPG) level ≥ 7.0 mmol/l (126 mg/dL)
  2. Plasma glucose ≥ 11.1 mmol/l (200 mg/dL) two hours after a 75 g oral glucose load as in a glucose tolerance test
  3. Symptoms of hyperglycemia and casual plasma glucose ≥ 11.1 mmol/l (200 mg/dL)
  4. Glycated hemoglobin (A1C) ≥ 6.5% if any of followings is identified the participant is regarded as pre-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
hypertriglyceridemia
Serum triglyceride ≥150 mg/dL
Low high density lipoprotein -cholesterol (HDL-c)
Serum HDL-C of <40 mg/dL for men, <50 mg/dL for women,

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

November 5, 2016

First Submitted That Met QC Criteria

November 5, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 5, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Metabolic Syndrome X

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

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