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Clinical Trials/NCT02448498
NCT02448498
Completed
N/A

Strength Training Regimen for Normal Weight Diabetics

Stanford University1 site in 1 country289 target enrollmentFebruary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Stanford University
Enrollment
289
Locations
1
Primary Endpoint
Change in Hemoglobin A1c across study visits
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
July 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Latha Palaniappan, MD, MS

Professor

Stanford University

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

Outcomes

Primary Outcomes

Change in Hemoglobin A1c across study visits

Time Frame: Baseline, monthly (for 9 months), 9-Months

Secondary Outcomes

  • 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)
  • 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)

Study Sites (1)

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