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Sponsors and Collaborators: |
University of San Francisco University of California, San Francisco |
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Information provided by: | University of San Francisco |
ClinicalTrials.gov Identifier: | NCT00341614 |
Type 2 diabetics (non-insulin-dependent) are more than five times as likely to suffer an initial myocardial infarction (MI; heart attack) compared to nondiabetics.Female diabetics in particular, have a higher mortality rate for coronary artery disease (CAD) than male diabetics.C-reactive protein measurement in the clinical setting enhances the detection of individuals who are at high risk for cardiovascular disease (CVD), by providing additional predictive value.
We propose to study the effects of a supervised exercise and diet intervention on cardiovascular disease risk in postmenopausal diabetic women. We will recruit 35 postmenopausal, sedentary type 2 diabetics who will undergo a 3 month exercise and dietary intervention. They will exercise 3 times a week for 30 min in a supervised setting. Exercise mode will be aerobic and self-selected (i.e. treadmill, bike) at an intensity level of 50-85% VO2peak. Blood glucose will be monitored before and after exercise. The dietary intervention will consist of 6 meetings with a registered dietitian.
The study is designed to test the following hypotheses:
Cardiovascular disease risk measures will be different following a 3-month exercise and diet intervention.
Health-related measures will be different following a 3-month exercise and diet intervention.
Condition | Intervention | Phase |
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Cardiovascular Diseases Diabetes Mellitus, Type 2 |
Behavioral: 3-month Exercise Training and Diet Education |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | The Effects of an Exercise and Diet Intervention on Cardiovascular Risk Factors in Postmenopausal Type 2 Diabetics |
Estimated Enrollment: | 35 |
Study Start Date: | June 2006 |
Study Completion Date: | May 2007 |
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
"Reasonable" control of diabetes
Exclusion Criteria:
Diabetes not in control
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Deborah Sellmeyer, M.D. | University of California, San Francisco |
Study ID Numbers: | FDF-05-06 |
Study First Received: | June 19, 2006 |
Last Updated: | August 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00341614 |
Health Authority: | United States: Institutional Review Board |
Exercise Diabetes Mellitus, Type 2 Postmenopause Diet |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Cardiovascular Diseases |