Study of How Exercise or Weight Loss Effects Metabolic Syndrome

NCT00292994 | Unknown

• 1 other identifier: 700-04-2001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome; Insulin Resistance; Obesity

Keywords

Metabolic Syndrome; Hyperlipidemia; Type 2 diabetes mellitus; Insulin resistance; Weight loss; Obesity; Exercise; Hypertension

Outcome Measures

Primary Outcomes (1)

• Metabolic Syndrome Score

Interventions

Exercise BEHAVIORAL

Weight Loss BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Yankton Clinical Research Alliance: lead
• University of South Dakota: collaborator
• Yankton Medical Clinic: collaborator
• Avera Sacred Heart Hospital: collaborator

Study Sites (1)

Yankton Medical Clinic

Yankton, South Dakota, 57078, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Obesity; Hyperlipidemias; Diabetes Mellitus, Type 2; Weight Loss; Motor Activity; Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Diabetes Mellitus; Endocrine System Diseases; Body Weight Changes; Behavior; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael S Hein, MD

  Yankton Medical Clinic

  PRINCIPAL INVESTIGATOR

• John L Williams, PhD

  Sanford School of Medicine at the University of South Dakota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 16, 2006
• Study Start: April 1, 2004
• Study Completion: January 1, 2006
• Last Updated: February 16, 2006

Record last verified: 2006-01

Locations

US (1)