- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00292994
Study of How Exercise or Weight Loss Effects Metabolic Syndrome
Exercise and Diet With Weight Loss in Metabolic Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Dakota
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Yankton, South Dakota, United States, 57078
- Yankton Medical Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: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.
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Exclusion Criteria: 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. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Metabolic Syndrome Score
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael S Hein, MD, Yankton Medical Clinic
- Principal Investigator: John L Williams, PhD, Sanford School of Medicine at the University of South Dakota
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 700-04-2001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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