Strength Training Regimen for Normal Weight Diabetics

Diabetes Mellitus Clinical Trial

— STRONG-D  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448498
• Other study ID #: 32113
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 2020

Study information

• Verified date: April 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Exercise Intervention

Locations

Country	Name	City	State
United States	Stanford	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c across study visits		Baseline, monthly (for 9 months), 9-Months
Secondary	Change in body composition across study visits, as measured using DEXA		Baseline, 9-Months
Secondary	Change in waist circumference across study visits		Baseline, 9-Months
Secondary	Change in blood pressure across study visits		Baseline, 9-Months
Secondary	Change in body weight across study visits		Baseline, 9-Months
Secondary	Changes in cardiorespiratory fitness, as measured by 6-minute walk test		Baseline, 9-Months
Secondary	Change in muscle strength and endurance, as measured by Biodex strength testing		Baseline, 9-Months
Secondary	Change in quality of life		Baseline, 9-Months
Secondary	Change in Dietary Intake, as measured by Food Frequency Questionnaire		Baseline, 9-Months