Strength Training Regimen for Normal Weight Diabetics (STRONG-D)

Stanford University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Behavioral: Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02448498

32113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 289 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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289 participants in 3 patient groups

Strength Training Only

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Intervention

Aerobic Training Only

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Intervention

Combination (Strength and Aerobic) Training

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Intervention