Strength Training Regimen for Normal Weight Diabetics

NCT ID: NCT02448498

Last Updated: 2021-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Strength Training Only

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.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Aerobic Training Only

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.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Combination (Strength and Aerobic) Training

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.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Interventions

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Exercise Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Latha Palaniappan, MD, MS

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Latha Palaniappan, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Stanford School of Medicine

Locations

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Stanford

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30625372 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37493759 (View on PubMed)

Other Identifiers

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32113

Identifier Type: -

Identifier Source: org_study_id

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