Obesity Clinical Trial - Three Lifestyle Interventions on Endothelial

Status Completed

Clinical Trial 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. pragmatic healthy style diet adapted to brazilian habits with portion control and pedometers to perform 10000 steps daily recorded or 3. pragmatic healthy style diet adapted to brazilian habits with portion control plus fitness three times a week under direct supervision. The main outcome was brachial reactivity, a surrogate marker of atherosclerosis, and secondary outcomes were cardiometabolic profile, arterial pressure and anthropometric measures: weight,waist circumference and bioimpedanciometry to access fat proportion and insulin sensitivity.

Clinical Trial 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 non-diabetic persons with metabolic syndrome without coronary heart disease.

After informed consent, they will be randomized to 3 different lifestyle interventions: 1. Hypocaloric tailored AHA type 1 diet plus standard exercise advice; 2. Pragmatic portion controlled healthy diet plus pedometers to perform 10.000 steps daily or 3. pragmatic portion controlled healthy diet plus fitness under direct supervision,using heart rate monitors to adjust workload to achieve the target heart rate (75% of the maximum attainable heart rate - HRpeak, as determined by their individual maximal treadmill exercise test).Main outcome is endothelium vasodilation accessed through brachial ultrasound, a surrogate marker of atherosclerosis. Secondary outcomes are anthropometric data: weight, waist circumference and fat proportion, cardiometabolic profile and insulin sensitivity (HOMA-R). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00943865
Study type	Interventional
Source	Hospital de Clinicas de Porto Alegre
Contact
Status	Completed
Phase	N/A
Start date	June 2007
Completion date	June 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Three Lifestyle Interventions on Endothelial Function and Cardiometabolic Risk in Obese Patients With Metabolic Syndrome

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms