Diabetes MellitusSTRONG-DNCT02448498
Strength Training Regimen for Normal Weight Diabetics
A study testing Exercise Intervention in people with Diabetes Mellitus, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Plans to be away for more than four weeks
- Medical conditions which would prevent long-term participation or which would contraindicate physical activity
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Exercise Intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c across study visits
Measured: Baseline, monthly (for 9 months), 9-Months
Secondary outcomes (8)
Change in body composition across study visits, as measured using DEXA
Measured: Baseline, 9-Months
Change in waist circumference across study visits
Measured: Baseline, 9-Months
Change in blood pressure across study visits
Measured: Baseline, 9-Months
Change in body weight across study visits
Measured: Baseline, 9-Months
Changes in cardiorespiratory fitness, as measured by 6-minute walk test
Measured: Baseline, 9-Months
Change in muscle strength and endurance, as measured by Biodex strength testing
Measured: Baseline, 9-Months
Change in quality of life
Measured: Baseline, 9-Months
Change in Dietary Intake, as measured by Food Frequency Questionnaire
Measured: Baseline, 9-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startFeb 2016
- Primary completionJul 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Principal investigator, Latha Palaniappan, MD, MS, Stanford University
- Investigators
- Latha Palaniappan, MD, MS, Principal investigator, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448498
- Sponsor's protocol ID
- 32113
- Acronym
- STRONG-D
- Status last verified
- Apr 2021
- First submitted
- 6 Mar 2015
- Last updated
- 12 Apr 2021
- Results posted
- No
Publications
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.
PubMed 30625372Kobayashi 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.
PubMed 37493759
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training Regimen for Normal Weight Diabetics
- ClinicalTrials.gov ID
- NCT02448498
- Acronym / sponsor ID
- STRONG-D / 32113
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Study start
- Feb 2016
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strength Training Only | Experimental | Behavioral: Exercise InterventionParticipants 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. |
| Aerobic Training Only | Experimental | Behavioral: Exercise InterventionParticipants 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. |
| Combination (Strength and Aerobic) Training | Experimental | Behavioral: Exercise InterventionParticipants 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Intervention | Behavioural | Aerobic Training Only, Combination (Strength and Aerobic) Training, Strength Training Only |
Primary outcome
Change in Hemoglobin A1c across study visits
Time frame: Baseline, monthly (for 9 months), 9-Months
8 secondary outcomes
Change in body composition across study visits, as measured using DEXA
Time frame: Baseline, 9-Months
Change in waist circumference across study visits
Time frame: Baseline, 9-Months
Change in blood pressure across study visits
Time frame: Baseline, 9-Months
Change in body weight across study visits
Time frame: Baseline, 9-Months
Changes in cardiorespiratory fitness, as measured by 6-minute walk test
Time frame: Baseline, 9-Months
Change in muscle strength and endurance, as measured by Biodex strength testing
Time frame: Baseline, 9-Months
Change in quality of life
Time frame: Baseline, 9-Months
Change in Dietary Intake, as measured by Food Frequency Questionnaire
Time frame: Baseline, 9-Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Background: PubMed 30625372Faroqi 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.
- Derived from this study: PubMed 37493759Kobayashi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Latha Palaniappan, MD, MS principal investigator
Stanford School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Diabetes Mellitus, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c across study visits (time frame: Baseline, monthly (for 9 months), 9-Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02448498, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.