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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Exercise Intervention

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 Type: Interventional
• Enrollment (Actual): 289
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strength Training Only; 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
Experimental: Aerobic Training Only; 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
Experimental: Combination (Strength and Aerobic) Training; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Latha Palaniappan, MD, MS, Stanford School of Medicine

Publications and helpful links

General Publications

• Faroqi L, Bonde S, Goni DT, Wong CW, Wong M, Walai K, Araya S, Azamey S, Schreiner G, Bandy M, Raghuram SS, Mittal A, Mukherji A, Wangdak T, Talamoa R, Vera K, Nacif-Coelho C, Cde LG, Christensen M, Johannsen N, Haddad F, Moharir M, Palaniappan L. STRONG-D: Strength training regimen for normal weight diabetics: Rationale and design. Contemp Clin Trials. 2019 Mar;78:101-106. doi: 10.1016/j.cct.2019.01.005. Epub 2019 Jan 6.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: March 6, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 32113