Status:
UNKNOWN
Study of How Exercise or Weight Loss Effects Metabolic Syndrome
Lead Sponsor:
Yankton Clinical Research Alliance
Collaborating Sponsors:
University of South Dakota
Yankton Medical Clinic
Conditions:
Metabolic Syndrome
Insulin Resistance
Eligibility:
FEMALE
18+ years
Phase:
NA
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 foun...
Detailed Description
Research procedures: The interventions in this study will be caloric dietary restrictions intended to result in a 10% reduction of body weight within 6 months, or a supervised aerobic exercise program...
Eligibility Criteria
Inclusion
- Subjects who have been noted to meet the initial study criteria or have self-determined their eligibility from direct mailings, newspaper advertisement, or poster/flyers (female, age \> 18, and a BMI of \> 30) will contact the study coordinator. Subjects will come for an initial assessment where informed consent will be obtained. Their eligibility for inclusion or exclusion will be based on a determination that they do have metabolic syndrome and determined by the study coordinator (Janine Albers) and the principal investigators (Michael Hein or Jack Williams). This will be assessed by a review of their medical record, laboratory assessment, anthropomorphic measurements, and a focused History and Physical examination.
- \-
Exclusion
- Cardiovascular: uncontrolled dyslipidemia (fasting triglycerides \> 1000), type 1 diabetes, uncontrolled type 2 diabetes (Hgb A-1-c \> 9.0%) or if on insulin, or uncontrolled hypertension (SBP \> 180 or DBP \> 100). Also, subjects with stable or unstable angina, a precedent myocardial infarction within six months of the study, or severe activity dyspnea, untreated major depression or patients with suicidal ideation, severe exercise-limiting inflammatory or degenerative arthritis, patients on anti-obesity medications or serotonin reuptake inhibitors, patients who are already involved in a regular aerobic exercise program (\> 3 sessions of 30min/wk) or are involved with other weight loss programs with dietary regimen intervention as a component, e.g. Weight Watchers or other similarly structured weight loss programs. Pregnancy. Weigh greater than 350 pounds. -
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00292994
Start Date
April 1 2004
End Date
January 1 2006
Last Update
February 16 2006
Active Locations (1)
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1
Yankton Medical Clinic
Yankton, South Dakota, United States, 57078