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

NCT ID: NCT01586754

Last Updated: 2012-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Syndrome Subclinical Organ Damage Overweight Obese

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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With Metabolic Syndrome

No interventions assigned to this group

Without Metabolic Syndrome

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Goztepe Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Esra Ekiz

Medical Doctor/Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ESRA EKIZ, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University Goztepe Training and Research Hospital

Locations

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Istanbul Medeniyet University Goztepe Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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34

Identifier Type: -

Identifier Source: org_study_id

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