Strength Training Regimen for Normal Weight Diabetics

Study Overview
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Brief Summary
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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
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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.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength Training Only<br>Participants in the strength-training only group will take part in a 9-month exercise intervention at a local exercise facility. They will engage in strength training 3 days per week for approximately 60 minutes each exercise session. | Behavioral: Exercise Intervention<br> <br> |
| Experimental: Aerobic Training Only<br>Participants in the aerobic training only group will take part in a 9-month exercise intervention at a local exercise facility. They will engage in aerobic training over 3 -5 days per week to achieve the targeted dose of 12 kcal/kg per week at a training intensity between 50-80% VO2 max. | Behavioral: Exercise Intervention<br> <br> |
| Experimental: Combination (Strength and Aerobic) Training<br>Participants in the combination (strength and aerobic training) group will take part in a 9-month exercise intervention at a local exercise facility. They will engage aerobic training that will expend 10 kcal/kg/week in combination with strength-training, 3 days per week. | Behavioral: Exercise Intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c across study visits |  | Baseline, monthly (for 9 months), 9-Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body composition across study visits, as measured using DEXA |  | Baseline, 9-Months | 
| 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 | 
| Changes in cardiorespiratory fitness, as measured by 6-minute walk test |  | 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 |