Skip to main content
OpenTrials
Completed

NCT Number: NCT02448498

Strength Training Regimen for Normal Weight Diabetics

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

Primary outcomes

  1. Change in Hemoglobin A1c across study visits

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

Secondary outcomes

  1. Change in body composition across study visits, as measured using DEXA

    Time frame: Baseline, 9-Months

  2. Change in waist circumference across study visits

    Time frame: Baseline, 9-Months

  3. Change in blood pressure across study visits

    Time frame: Baseline, 9-Months

  4. Change in body weight across study visits

    Time frame: Baseline, 9-Months

  5. Changes in cardiorespiratory fitness, as measured by 6-minute walk test

    Time frame: Baseline, 9-Months

  6. Change in muscle strength and endurance, as measured by Biodex strength testing

    Time frame: Baseline, 9-Months

  7. Change in quality of life

    Time frame: Baseline, 9-Months

  8. Change in Dietary Intake, as measured by Food Frequency Questionnaire

    Time frame: Baseline, 9-Months

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Pennington Biomedical Research Center

Registry information

Acronym: STRONG-D

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 19, 2015
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.