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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

Tracking Information
First Submitted Date November 5, 2016
First Posted Date November 8, 2016
Last Update Posted Date November 8, 2016
Study Start Date January 2005
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2016)
  • incidence of CVD [ Time Frame: 10 years ]
  • incidence of microvascular complications of T2D (diabetic retinopathy, diabetic neuropathy, diabetic kidney disease), and diabetic foot [ Time Frame: 10 years ]
  • incidence of non-alcoholic fatty liver disease (NAFLD) [ Time Frame: 10 years ]
  • incidence of colorectal, breast and cervical cancers [ Time Frame: 10 years ]
  • mortality rate [ Time Frame: 10 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 5, 2016)
economic burden of metabolic syndrome [ Time Frame: 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title a Population Based Study on Metabolic Syndrome Complications, and Mortality
Official Title A Population Based Cohort Study on Metabolic Syndrome Complications, and Mortality; (MetSCoM) Study
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
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Metabolic Syndrome X
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.
Study Groups/Cohorts
  • Obesity
    Body mass index (BMI) score > 25.2 kg/m2 for women and > 27.3 kg/m2 for men or Waist circumference > 90 cm
    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.
  • 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)

    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.
  • Hypertension
    Systolic blood pressure (SBP) ≥ 130mmHgand/or diastolic blood pressure (DBP) ≥ 85mmHg or use of anti-hypertensive drugs
    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.
  • hypertriglyceridemia
    Serum triglyceride ≥150 mg/dL
    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.
  • Low high density lipoprotein -cholesterol (HDL-c)
    Serum HDL-C of <40 mg/dL for men, <50 mg/dL for women,
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 5, 2016)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Alireza Esteghamati, MD esteghamati@tums.ac.ir
Contact: Zahra Aryan, MD, MPH aryanzahra@yahoo.com
Listed Location Countries Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02958579
Other Study ID Numbers 95-03-191-33053
957275 ( Other Grant/Funding Number: National Institute for Medical Research Development (NIMAD) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tehran University of Medical Sciences
Study Sponsor Tehran University of Medical Sciences
Collaborators Not Provided
Investigators
Principal Investigator: Mohsen Afarideh, MD, MPH Tehran University of Medical Sciences
Principal Investigator: Alireza Ghajar, MD Tehran University of Medical Sciences
PRS Account Tehran University of Medical Sciences
Verification Date November 2016