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

NCT01586754 | Unknown

• 1 other identifier: 34
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome; Subclinical Organ Damage; Overweight; Obese

Keywords

metabolic syndrome; obesity; endothelial damage; homocysteine; microalbumin; carotis intima-media thickness

Study Arms (2)

With Metabolic Syndrome

Without Metabolic Syndrome

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese or overweight patients, aged between 18-80 who are non-smokers, with a GFR \> 60 ml/min and without any history of diabetes (insulin dependent or non-insulin dependent), coronary artery disease or peripheral arterial disease, attending to hyperlipidemia and obesity outpatient clinic.

You may qualify if:

• years
• BMI \>= 25
• Ex or non-smokers (must have quit smoking at least 5 years ago)

You may not qualify if:

• NIDDM or IDDDM
• Nephropathy (GFR \< 60 ml/min), previous history of coronary artery disease or peripheral arterial disease
• Current smokers
• Active infection or other acute illness

Sponsors & Collaborators

• Goztepe Training and Research Hospital: lead

Study Sites (1)

Istanbul Medeniyet University Goztepe Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be drawn from patients for routine biochemical analyses for glucose, urea, creatinine, liver function tests, thyroid function tests, electrolytes and homocysteine and also glucose tolerance test. Spot urine samples will be drawn for assessment of microalbuminuria.

MeSH Terms

Conditions

Metabolic Syndrome; Overweight; Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ESRA EKIZ, MD

  Istanbul Medeniyet University Goztepe Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor/Resident

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 27, 2012
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 27, 2012

Record last verified: 2012-04

Locations

TU (1)