Exercise Training in Older Diabetic Women
Completed · Phase 1
Conditions studied: Cardiovascular Diseases, Diabetes Mellitus, Type 2
In brief
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. * H1: Blood markers for coronary artery disease risk, as measured by CRP, TC, LDL, TG, FG, fasting insulin, and HbA1c, will be different following a 3-month exercise and diet intervention. * H2: Anthropometric measures of coronary artery disease risk, as measured by WHR, will be different following a 3-month exercise and diet intervention. * H3: Resting blood pressure, as measured by SBP and DBP, will be different following a 3-month exercise and diet intervention. * H4: Total body fat, as measured by DXA, 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. * H1: Cardiorespiratory fitness, as measured by maximal oxygen consumption (VO2max) will be different following a 3-month exercise and diet intervention. * H2: Bone-mineral density, as measured by DXA, will be different following a 3-month exercise and diet intervention. * H3: Dietary measures (total daily kcal, and daily fat kcal) will be different following a 3-month exercise and diet intervention.
Key facts
- Study ID
- NCT00341614
- Run by
- University of San Francisco
- People needed
- 35
- Starts
- 2006-06-01
- Expected to finish
- 2007-05-01
- Last updated by the study team
- 2007-08-16
Who can join
Age: 45 and older, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female 45-75 yrs old
- Type 2 diabetic for > 6 months
- "Reasonable" control of diabetes
- blood glucose within 100-250 mg/dl prior to exercise
- absence of hypoglycemic symptoms
- diabetes control verified by physician
- cleared by physician to begin exercise program
- Postmenopausal > 6 months
- Sedentary
- Ability and willingness of patient to give written, informed consent
- Able and willing to participate in an exercise intervention
You may not qualify if…
- Diabetes not in control
- unable to maintain blood glucose within 100-250 mg/dl
- development of urinary ketone bodies (ketosis)
- symptoms of hypoglycemia before, during, and post-exercise
- no physician's approval to participate
- Male
- Female <45 or >75 yr
- > 300 lb (weight limit for DXA table)
- On insulin
- Contraindications to Exercise Testing (ACSM, 2000)
- Ischemia
- Recent myocardial infarction
- Unstable angina
- Uncontrolled cardiac arrhythmias
- Severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus
- Acute myocarditis or pericarditis
- Dissecting aneurysm
- Acute infections
- Electrolyte abnormalities
- Severe hypertension (SBP > 200 mm Hg, DBP > 110 mm Hg at rest)
- Tachyarrhythmias or bradyarrhythmias
- Hypertrophic cardiomyopathy
- Neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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