Clinical trial NCT02448498: Strength Training Regimen for Normal Weight Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Pennington Biomedical Research Center
First posted: 2015-05-19
Enrollment: 289
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hemoglobin A1c across study visits
timeFrame: Baseline, monthly (for 9 months), 9-Months
Secondary outcomes:
measure: Change in body composition across study visits, as measured using DEXA
timeFrame: Baseline, 9-Months
measure: Change in waist circumference across study visits
timeFrame: Baseline, 9-Months
measure: Change in blood pressure across study visits
timeFrame: Baseline, 9-Months
measure: Change in body weight across study visits
timeFrame: Baseline, 9-Months
measure: Changes in cardiorespiratory fitness, as measured by 6-minute walk test
timeFrame: Baseline, 9-Months
measure: Change in muscle strength and endurance, as measured by Biodex strength testing
timeFrame: Baseline, 9-Months
measure: Change in quality of life
timeFrame: Baseline, 9-Months
measure: Change in Dietary Intake, as measured by Food Frequency Questionnaire
timeFrame: Baseline, 9-Months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford School of Medicine
name: Latha Palaniappan, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.