Study of How Exercise or Weight Loss Effects Metabolic Syndrome

Status unconfirmed · Not applicable

Conditions studied: Metabolic Syndrome, Insulin Resistance, Obesity

In brief

The Metabolic Syndrome (MS) is prevalent in the American population and is strongly associated with premature coronary disease. Lifestyle intervention, primarily exercise and dietary changes, are foundational treatment strategies for independent components of MS, but these interventions have not been thoroughly evaluated in MS. Even with very modest weight loss, in the setting of caloric restriction and exercise, marked improvement MS parameters have been noted. However, it is not known whether it is diet with weight loss or exercise that improves the metabolic derangements associated with MS. We propose a study designed to examine the relative impact of diet or exercise on the components of MS. Furthermore, it is known that psychological factors significantly impact the ability of patients to initiate and sustain lifestyle changes. We will monitor certain psychological states to evaluate their impact on the success of weight loss and sustainability of lifestyle changes throughout this study. Specific Aims: 1.) Evaluate the relative efficacy of diet with weight loss or exercise on improving the markers of metabolic syndrome. 2.) Determine of pre-existing psychological factors influence the effectiveness of diet with weight loss or exercise on the markers of metabolic syndrome. Design: Adult women (\> 18 yrs) with a body-mass index (BMI)  30 kg/m2 will be assessed for MS and randomized to one of three groups (n = 34/group), Control (C), diet with weight loss alone (D), or exercise alone (E). The intervention groups will participate in supervised dietary changes designed for weight loss or exercise for 6 months. Anthropomorphic, serologic, and psychological parameters will be monitored and compared using ANOVA. Hypothesis: As indexed by the improvement in the laboratory markers of the components of metabolic syndrome, exercise alone has a more profound positive impact on Metabolic Syndrome then diet with weight loss alone.

Key facts

Study ID
NCT00292994
Run by
Yankton Clinical Research Alliance
People needed
130
Starts
2004-04-01
Expected to finish
2006-01-01
Last updated by the study team
2006-02-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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