Status:
COMPLETED
Exercise Dose-Response on Features of the Metabolic Syndrome
Lead Sponsor:
Charles Drew University of Medicine and Science
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Insulin Resistance
Metabolic Syndrome
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study investigates the degree of improvement in insulin resistance and features of the metabolic syndrome in non-diabetic overweight or obese subjects after training in a low-intensity, moderate-...
Detailed Description
The proposed study is a randomized, open study comparing low-intensity and moderate-intensity aerobic exercise versus non-aerobic (stretching) exercise on direct measurements of insulin resistance and...
Eligibility Criteria
Inclusion
- Males or females, age 18-60
- At least 2 of the 5 components of the NCEP definition of the metabolic syndrome, provided that either the triglyceride or waist circumference criteria are met
- Body mass index of 25-45 kg/m2
- Subjects not currently following a regular exercise program nor an optimal diet, and who self-report their activity level as sedentary
- Able to understand and sign the informed consent form, follow the instructions given in the study, attend all necessary clinic visits, and undergo all required study procedures
Exclusion
- Past or current diabetes mellitus
- Significant concurrent medical illnesses (chronic liver or renal disease, malignancies, recent or chronic infections including HIV, surgeries or other hospitalizations within four weeks prior to screening), uncontrolled hypertension (BP \>160/90 mm Hg), or abnormal TSH on screening.
- Conditions that may contraindicate physical activity (clinically significant cardiac, pulmonary, orthopedic, rheumatological or neurological diseases)
- Cardiovascular disease not controlled with medical therapy, or invasive vascular procedures within six months prior to screening
- Subjects found on resting EKG or stress testing to have underlying cardiac abnormalities
- Perimenopausal women who are experiencing irregular menses
- Pregnant or lactating women
- Subjects who may have limited exercise tolerance because of treatment with β-adrenergic blockade agents, at least until agents of alternate drug classes can be substituted
- Subjects with concurrent endocrinopathies
- Subjects receiving concurrent treatment with metformin, thiazolidinediones, systemic glucocorticoids, or any weight loss agents
- Subjects who expect to require medications during the course of the study that may affect their metabolic profile, including systemic glucocorticoids and hormone replacement therapies
- Subjects who cannot complete the stress test due to physical limitations
- Any other factors that, in the opinion of the investigators, may interfere with the safe conduct, the successful completion, or the quality of the data obtained from the study
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00687128
Start Date
October 1 2004
End Date
April 1 2010
Last Update
February 28 2012
Active Locations (1)
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1
Charles Drew University of Medicine and Science
Los Angeles, California, United States, 90059