Clinical trial NCT02958579: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome X
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 10000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: incidence of CVD
timeFrame: 10 years
measure: incidence of microvascular complications of T2D (diabetic retinopathy, diabetic neuropathy, diabetic kidney disease), and diabetic foot
timeFrame: 10 years
measure: incidence of non-alcoholic fatty liver disease (NAFLD)
timeFrame: 10 years
measure: incidence of colorectal, breast and cervical cancers
timeFrame: 10 years
measure: mortality rate
timeFrame: 10 years
Secondary outcomes:
measure: economic burden of metabolic syndrome
timeFrame: 10 years
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mohsen Afarideh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Sciences
name: Alireza Ghajar, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.e5. doi: 10.1016/j.ahj.2015.06.017. Epub 2015 Jun 27.
citation: 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.
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;244:165-71. doi: 10.1016/j.atherosclerosis.2015.11.020. Epub 2015 Nov 23.
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):e189. doi: 10.2337/dc16-1211. No abstract available.
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. 2017 Apr;43(2):180-183. doi: 10.1016/j.diabet.2016.07.032. Epub 2016 Sep 17. No abstract available.
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):55-61. doi: 10.1016/j.diabet.2015.10.001. Epub 2015 Oct 31.
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.2014.02.001. Epub 2014 Mar 14.
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 May-Jun;8(3):279-86. doi: 10.1016/j.jacl.2014.02.002. Epub 2014 Feb 15.
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.2013.0119. Epub 2014 Jan 21.
citation: 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.