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

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ClinicalTrials.gov Identifier: NCT02958579
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief 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

Condition or disease Intervention/treatment
Metabolic Syndrome X Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.

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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Population Based Cohort Study on Metabolic Syndrome Complications, and Mortality; (MetSCoM) Study
Study Start Date : January 2005
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2020

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

Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.
Hypertension
Systolic blood pressure (SBP) ≥ 130mmHgand/or diastolic blood pressure (DBP) ≥ 85mmHg or use of anti-hypertensive drugs
Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.
hypertriglyceridemia
Serum triglyceride ≥150 mg/dL
Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.
Low high density lipoprotein -cholesterol (HDL-c)
Serum HDL-C of <40 mg/dL for men, <50 mg/dL for women,
Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.



Primary Outcome Measures :
  1. incidence of CVD [ Time Frame: 10 years ]
  2. incidence of microvascular complications of T2D (diabetic retinopathy, diabetic neuropathy, diabetic kidney disease), and diabetic foot [ Time Frame: 10 years ]
  3. incidence of non-alcoholic fatty liver disease (NAFLD) [ Time Frame: 10 years ]
  4. incidence of colorectal, breast and cervical cancers [ Time Frame: 10 years ]
  5. mortality rate [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. economic burden of metabolic syndrome [ Time Frame: 10 years ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958579


Contacts
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Contact: Alireza Esteghamati, MD esteghamati@tums.ac.ir
Contact: Zahra Aryan, MD, MPH aryanzahra@yahoo.com

Locations
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Iran, Islamic Republic of
Tehran University of Medical Sciences Recruiting
Tehran, Iran, Islamic Republic of, 13145-784
Contact: Alireza Esteghamati, M.D.       esteghamati@tums.ac.ir   
Contact: Zahra Aryan, MD, MPH       aryanzahra@yahoo.com   
Principal Investigator: Mohsen Afarideh, M.D.         
Principal Investigator: Alireza Ghajar, MD         
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Mohsen Afarideh, MD, MPH Tehran University of Medical Sciences
Principal Investigator: Alireza Ghajar, MD Tehran University of Medical Sciences

Publications of Results:

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02958579     History of Changes
Other Study ID Numbers: 95-03-191-33053
957275 ( Other Grant/Funding Number: National Institute for Medical Research Development (NIMAD) )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases