Metabolic Syndrome XMetSCoMNCT02958579
a Population Based Study on Metabolic Syndrome Complications, and Mortality
An observational study of Metabolic Syndrome X, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Metabolic Syndrome X
- Type of treatment
- Pill or oral medicine
- How many people
- 10,000 participants
- Where
- 1 siteIran
- Study dates
- Jan 2005to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Alireza Esteghamati, MD contact
Zahra Aryan, MD, MPH contact
Iran1 site, 1 recruiting
- Recruiting
Tehran University of Medical Sciences
Tehran, Tehran Province, 13145-784
Alireza Esteghamati, M.D., esteghamati@tums.ac.ir
Zahra Aryan, MD, MPH, aryanzahra@yahoo.com
About this study
Official title: 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;
- 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.
- 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.
- To find the effect of behavioral variables and environmental exposures on the course of metabolic syndrome.
- To identify the best anthropometric, laboratory, life-style and environmental predictors of CVD and mortality rate in subjects with metabolic syndrome.
- To estimate the economic burden of metabolic syndrome and its related
Read the 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.
- Conditions
- Metabolic Syndrome X
- Being tested
- No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.Other
| Study group | Role | What they receive |
|---|---|---|
| Obesity | Body mass index (BMI) score > 25.2 kg/m2 for women and > 27.3 kg/m2 for men or Waist circumference > 90 cm Receives: 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) Receives: 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 Receives: 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 Receives: 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, Receives: Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of CVD
Measured: 10 years
incidence of microvascular complications of T2D (diabetic retinopathy, diabetic neuropathy, diabetic kidney disease), and diabetic foot
Measured: 10 years
incidence of non-alcoholic fatty liver disease (NAFLD)
Measured: 10 years
incidence of colorectal, breast and cervical cancers
Measured: 10 years
mortality rate
Measured: 10 years
Secondary outcomes (1)
economic burden of metabolic syndrome
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startJan 2005
- Primary completionJan 2017 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohsen Afarideh, MD, MPH, Principal investigator, Tehran University of Medical SciencesAlireza Ghajar, MD, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958579
- Sponsor's protocol ID
- 95-03-191-33053
- Other IDs
- 957275
- Acronym
- MetSCoM
- Status last verified
- Nov 2016
- First submitted
- 5 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
Publications
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.
PubMed 26385042Afarideh 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.
PubMed 27684605Nargesi 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.
PubMed 26647372Aryan 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.
PubMed 27660132Afarideh 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.
PubMed 27644597Faghihi-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.
PubMed 26531321Esteghamati 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.
PubMed 24631466Esteghamati 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.
PubMed 24793349Sheikhbahaei 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.
PubMed 24447037Aryan 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.
PubMed 29694948
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population Based Cohort Study on Metabolic Syndrome Complications, and Mortality; (MetSCoM) Study
- ClinicalTrials.gov ID
- NCT02958579
- Acronym / sponsor ID
- MetSCoM / 95-03-191-33053
- Conditions
- Metabolic Syndrome X
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- 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.
- 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.
- To find the effect of behavioral variables and environmental exposures on the course of metabolic syndrome.
- To identify the best anthropometric, laboratory, life-style and environmental predictors of CVD and mortality rate in subjects with metabolic syndrome.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.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 | – | Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.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 | – | Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.Systolic blood pressure (SBP) ≥ 130mmHgand/or diastolic blood pressure (DBP) ≥ 85mmHg or use of anti-hypertensive drugs |
| hypertriglyceridemia | – | Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.Serum triglyceride ≥150 mg/dL |
| Low high density lipoprotein -cholesterol (HDL-c) | – | Other: No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.Serum HDL-C of <40 mg/dL for men, <50 mg/dL for women, |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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,)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study. | Other | Hypertension, Low high density lipoprotein -cholesterol (HDL-c), Obesity, Pre-diabetics or diabetics, hypertriglyceridemia |
Primary outcome
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
1 secondary outcome
economic burden of metabolic syndrome
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Results publication: PubMed 26385042Heidari 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.
- Results publication: PubMed 27684605Afarideh 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.
- Results publication: PubMed 26647372Nargesi 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.
- Results publication: PubMed 27660132Aryan 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.
- Results publication: PubMed 27644597Afarideh 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.
- Results publication: PubMed 26531321Faghihi-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.
- Results publication: PubMed 24631466Esteghamati 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.
- Results publication: PubMed 24793349Esteghamati 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.
- Results publication: PubMed 24447037Sheikhbahaei 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.
- Derived from this study: PubMed 29694948Aryan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alireza Esteghamati, MD contact
Zahra Aryan, MD, MPH contact
Mohsen Afarideh, MD, MPH principal investigator
Tehran University of Medical Sciences
Alireza Ghajar, MD principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome X, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alireza Esteghamati, MD (esteghamati@tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of CVD (time frame: 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958579, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.