Exercise Training in Older Diabetic Women

NCT00341614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2007-08-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

3-month Exercise Training and Diet Education

Sponsors & Collaborators

Principal Investigators

  • Deborah Sellmeyer, M.D. · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Completion
2007-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00341614 on ClinicalTrials.gov