Strength Training Regimen for Normal Weight Diabetics

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Exercise Intervention

• Registration Number: NCT02448498
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Study Start: 2016-02
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strength Training Only	Exercise Intervention	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.
Aerobic Training Only	Exercise Intervention	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.
Combination (Strength and Aerobic) Training	Exercise Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c across study visits	Baseline, monthly (for 9 months), 9-Months

Secondary Outcome Measures

Name	Time	Method
Change in muscle strength and endurance, as measured by Biodex strength testing	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
Change in quality of life	Baseline, 9-Months
Change in body composition across study visits, as measured using DEXA	Baseline, 9-Months
Change in body weight across study visits	Baseline, 9-Months
Change in waist circumference across study visits	Baseline, 9-Months
Change in blood pressure across study visits	Baseline, 9-Months

Trial Locations

Locations (1)

Stanford; 🇺🇸 Palo Alto, California, United States