Status:
COMPLETED
Three Lifestyle Interventions on Endothelial Function and Cardiometabolic Risk in Obese Patients With Metabolic Syndrome
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Metabolic Syndrome
Obesity
Eligibility:
All Genders
30-55 years
Phase:
NA
Brief Summary
Obese patients with metabolic syndrome without diabetes or ischemic heart disease were randomized to three lifestyle interventions: 1. hypocaloric tailored diet with standard recommendations 2. pragma...
Detailed Description
It's a 12 week single center randomized controlled trial to evaluate three different lifestyle interventions on flow mediated vasodilatation, cardiometabolic profile and anthropometric parameters in n...
Eligibility Criteria
Inclusion
- men and women 30-55 years with BMI 30-40 and waist 95 cm or more
- normal OGTT
- normal treadmill stress test
- plus 2 of 4:
- low serum levels of HDL cholesterol (\<40 mg⁄dL for men or \< 50 mg ⁄dL for women);
- hypertriglyceridemia (triglyceride levels of 150 mg⁄dL or greater);
- impaired glucose homeostasis (fasting plasma glucose concentration of 110 mg⁄dL or greater or glucose of 140 mg⁄dL or greater after OGTT or
- hypertension (systolic blood pressure ≥ 140 or diastolic blood pressure ≥90 mmHg or treatment with antihypertensive drugs).
Exclusion
- diabetes
- ischemic heart disease or any abnormality on treadmill stress test
- inflammatory or chronic disorder
- pregnancy
- lactation
- creatinine level of 1,5 mg/dL or more
- gastrointestinal problems or musculoskeletal disorders that would prevent them to follow the test diets or exercise interventions
- liver dysfunction with a factor of at least 3 above the upper limit of normal in AST and ALT levels
- thyroid dysfunction, with serum TSH out of normal limits
- use of immunosuppressive drugs, corticosteroids or anorexigen
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00943865
Start Date
June 1 2007
End Date
June 1 2009
Last Update
July 22 2009
Active Locations (1)
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1
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903