University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: 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.
* 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.
Looking for future studies?
Notify Me45 year–75 year
Female
Interventional
Phase 1
San Francisco, California, 94143, United States
All participants will have a 12-lead electrocardiogram (ECG) during the testing sessions to monitor for dysrhythmias or ischemia. Heart rate and blood pressure will be monitored every 2 minutes. Rating of perceived exertion (RPE) will be assessed every minute of the test. Maximal oxygen uptake (VO2max), as well as maximal levels of blood pressure, heart rate, respiratory exchange ratio (RER), and RPE will be recorded at the end of the test and used to determine the exercise training intensity. Expired gases will be collected throughout the test with CO2 and O2 and volume analyzed for calculation of oxygen uptake using a Quinton QMC computerized gas analysis system (Quinton Instruments, Bothell WA). All exercise technicians will be CPR and first-aid certified.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
University of San Francisco
Other
The Effects of an Exercise and Diet Intervention on Cardiovascular Risk Factors in Postmenopausal Type 2 Diabetics
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