Diabetes Mellitus
Conditions
Brief summary
The Strength Training Regimen in Normal Weight Diabetics (STRONG-D) study will examine the effectiveness of different exercise regimen types in controlling diabetes for the normal weight type 2 diabetes population.
Detailed description
In the STRONG-D study, participants are randomly assigned to strength training, aerobic training or a combined strength and aerobic training group. Participants in the exercise group will attend exercise sessions over the course of 9 months at the YMCA. Participants will have opportunities to engage in other activities such as educational run-in visits that will allow for measurement of hemoglobin A1c and emphasize the importance of exercise in improving Type 2 diabetes.
Interventions
BEHAVIORALExercise Intervention
Sponsors
Pennington Biomedical Research Center
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Recent hemoglobin A1c result between 6.5%-13% * Diagnosis of Type 2 Diabetes Mellitus * BMI between 18.5 -25 kg/m2 * Blood pressure \< 160/100 * Sedentary lifestyle * Able and willing to enroll and meet requirements of the study
Exclusion criteria
* Age less than 30 years or greater than 75 years * Type 1 diabetes or use of insulin pump * Triglycerides \>500 mg/dL * Use of weight loss medication * Bariatric surgery * Consumes \>14 alcoholic drinks per week * Pregnancy * Plans to be away for more than four weeks * Medical conditions which would prevent long-term participation or which would contraindicate physical activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hemoglobin A1c across study visits | Baseline, monthly (for 9 months), 9-Months |
Secondary
| Measure | Time frame |
|---|---|
| Change in waist circumference across study visits | Baseline, 9-Months |
| Change in blood pressure across study visits | Baseline, 9-Months |
| Change in body weight across study visits | Baseline, 9-Months |
| Change in body composition across study visits, as measured using DEXA | Baseline, 9-Months |
| Change in muscle strength and endurance, as measured by Biodex strength testing | Baseline, 9-Months |
| Change in quality of life | Baseline, 9-Months |
| Change in Dietary Intake, as measured by Food Frequency Questionnaire | Baseline, 9-Months |
| Changes in cardiorespiratory fitness, as measured by 6-minute walk test | Baseline, 9-Months |
Countries
United States
Outcome results
None listed