NCT02448498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 12, 2021

Status Verified

April 1, 2021

Enrollment Period

4.4 years

First QC Date

March 6, 2015

Last Update Submit

April 7, 2021

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin A1c across study visits

    Baseline, monthly (for 9 months), 9-Months

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (3)

Strength Training Only

EXPERIMENTAL

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

Aerobic Training Only

EXPERIMENTAL

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

Combination (Strength and Aerobic) Training

EXPERIMENTAL

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

Interventions

Exercise InterventionBEHAVIORAL
Aerobic Training OnlyCombination (Strength and Aerobic) TrainingStrength Training Only

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford

Palo Alto, California, 94304, United States

Location

Related Publications (2)

  • 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.

    PMID: 30625372BACKGROUND

  • Kobayashi Y, Long J, Dan S, Johannsen NM, Talamoa R, Raghuram S, Chung S, Kent K, Basina M, Lamendola C, Haddad F, Leonard MB, Church TS, Palaniappan L. Strength training is more effective than aerobic exercise for improving glycaemic control and body composition in people with normal-weight type 2 diabetes: a randomised controlled trial. Diabetologia. 2023 Oct;66(10):1897-1907. doi: 10.1007/s00125-023-05958-9. Epub 2023 Jul 26.

    PMID: 37493759DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Latha Palaniappan, MD, MS

    Stanford School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2015

First Posted

May 19, 2015

Study Start

February 1, 2016

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

April 12, 2021

Record last verified: 2021-04

Locations

US(1)