a Population Based Study on Metabolic Syndrome Complications, and Mortality
NCT ID: NCT02958579
Last Updated: 2016-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
10000 participants
OBSERVATIONAL
2005-01-31
2020-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Obesity
Body mass index (BMI) score \> 25.2 kg/m2 for women and \> 27.3 kg/m2 for men or Waist circumference \> 90 cm
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)
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
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
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,
No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
40 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tehran University of Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mohsen Afarideh, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Tehran University of Medical Sciences
Alireza Ghajar, MD
Role: PRINCIPAL_INVESTIGATOR
Tehran University of Medical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tehran University of Medical Sciences
Tehran, Tehran Province, Iran
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Alireza Esteghamati, M.D.
Role: primary
Zahra Aryan, MD, MPH
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
957275
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
95-03-191-33053
Identifier Type: -
Identifier Source: org_study_id