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NCT01586754 Clinical Trial

Subclinical Organ Damage in Overweight and Obese Patients: Does Presence of Metabolic Syndrome Matter?

Metabolic Syndrome Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01586754
Other study ID # 34
Secondary ID
Status Unknown status
Phase N/A
First received April 25, 2012
Last updated April 26, 2012
Start date October 2011
Est. completion date May 2012

Study information
Verified date April 2012
Source Goztepe Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic and randomized clinical trials. Carotis intima-media thickness is also found to be elevated in early stages of atherosclerosis. Recent studies have shown correlations between homocysteine, microalbumin levels and carotis intima-media thickness in type 2 diabetics but no data exists for obese or overweight patients who also have metabolic syndrome, in terms of markers of subclinical organ damage. Since obesity is a risk factor for cardiovascular disease and since it is known that patients with metabolic syndrome are at higher risk of cardiovascular events, the investigators wanted to examine whether there is an association between homocysteine, microalbumin levels and carotid intima-media thickness in patients with or without metabolic syndrome, who are either overweight or obese.

Recruitment information / eligibility
Status Unknown status
Enrollment 100
Est. completion date May 2012
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. 18-80 years

2. BMI >= 25

3. Ex or non-smokers (must have quit smoking at least 5 years ago)

Exclusion Criteria:

1. NIDDM or IDDDM

2. Nephropathy (GFR < 60 ml/min), previous history of coronary artery disease or peripheral arterial disease

3. Current smokers

4. Active infection or other acute illness

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Istanbul Medeniyet University Goztepe Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Goztepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

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