Type 2 Diabetes Mellitus (T2DM)D-STORMNCT07664501
The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM)
A study testing D-STORM Resistance Training Programme in people with Type 2 Diabetes Mellitus (T2DM) and Sarcopenia, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial summary
Type 2 diabetes is associated with progressive loss of muscle mass, which worsens blood sugar control and increases the risk of heart disease and disability. Resistance training (weight training) has been shown to build muscle and improve blood sugar levels, but most existing programmes use high intensities that are… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Sarcopenia, Insulin Resistance
- What is being tested?
- D-STORM Resistance Training Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2027to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years
- Confirmed diagnosis of Type 2 Diabetes Mellitus
- HbA1c between 6.5% and 13.0%
- Not currently on insulin therapy
- Has a primary care provider
Who cannot join
- Age below 18 or above 65 years
- Blood pressure 160/100 mmHg or higher at screening
- HbA1c below 6.5% or above 13.0%
- Currently on insulin therapy
- Pregnant or planning to become pregnant within the next 6 months
- Serious medical conditions that would prevent safe participation in an exercise programme
- Any physical or functional limitation that would prevent participation in resistance training
- Underlying conditions that would not allow safe participation in the exercise intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Hospital Sultan Al-Abdullah (HASA)
Kuala Selangor, Selangor, 42300
About this study
Official title: The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM): Rationale and Study Protocol for a Randomized Controlled Trial
Type 2 diabetes is associated with progressive loss of muscle mass, which worsens blood sugar control and increases the risk of heart disease and disability. Resistance training (weight training) has been shown to build muscle and improve blood sugar levels, but most existing programmes use high intensities that are difficult for older or inactive people with diabetes to sustain.
This study tests a new resistance training programme called D-STORM (Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population), which uses a lower, more manageable training load designed to be safe, tolerable, and effective for adults with Type 2 diabetes who are not on insulin.
Participants will be randomly assigned to either twice-weekly D-STORM training plus their usual diabetes care, or usual care alone, for 12 weeks. The main outcome measured is change in HbA1c (a blood test reflecting average blood sugar over 3 months). Body composition, walking capacity, blood pressure, heart rate, and quality of life will also be measured.
Read the detailed description
The D-STORM trial is a 2-arm parallel randomised controlled trial conducted at Hospital Sultan Al-Abdullah (HASA), Puncak Alam, Selangor, Malaysia. Adults aged 18 to 65 years with Type 2 diabetes mellitus (HbA1c 6.5% to 13.0%) who are not on insulin therapy will be recruited and randomly allocated 1:1 to the D-STORM intervention arm or the usual care arm.
The D-STORM programme consists of 6 compound resistance exercises performed twice weekly on non-consecutive days for 12 weeks, at 60-80% of one-repetition maximum (1RM), 2 working sets per exercise, using the double progression model with sets terminated at 1-3 repetitions in reserve (RIR).
The primary outcome is between-group difference in HbA1c (%) from baseline to 12 weeks, with a minimum clinically important difference of 1.0% absolute reduction. Secondary outcomes include body composition (bioelectrical impedance analysis; InBody 270), functional exercise capacity (Incremental Shuttle Walk Test), blood pressure, resting heart rate, and health-related quality of life (SF-36). Sample size: 124 participants (62 per arm), accounting for 10% dropout.
- Being tested
- D-STORM Resistance Training Programme, usual care
- Keywords
- Type 2 diabetes mellitus, Resistance training, Muscular hypertrophy, Glycaemic control, HbA1c, Cardiometabolic outcomes, Randomised controlled trial, Minimal effective dose
- Medical subject headings
- Diabetes Mellitus, Type 2, Sarcopenia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-STORM Resistance Training ProgrammeBehavioural
Twice-weekly progressive resistance training comprising 6 compound exercises (upper body pull, upper body push, lower body push, lower body pull) at 60-80% 1RM, 2 working sets per exercise per session (minimum 4 sets per muscle group per week), 8-12 repetitions per set, terminated at 1-3 repetitions in reserve. Load is progressively increased using the double progression model. Total intervention duration is 12 weeks.
usual careOther
Participants receive standard diabetes care in accordance with the Malaysian Clinical Practice Guidelines for Type 2 Diabetes Management (6th Edition), including general physical activity recommendations of at least 150 minutes of moderate-intensity aerobic activity per week distributed over at least 3 days, with resistance exercise on a minimum of 2 non-consecutive days per week. No structured, supervised, or progressive training is provided.
| Study group | Role | What they receive |
|---|---|---|
| D-STORM Training plus Usual Care | Experimental | Participants perform the D-STORM resistance training programme twice weekly on non-consecutive days for 12 weeks, comprising 6 compound exercises at 60-80% 1RM, 2 working sets per exercise, terminated at 1-3 repetitions in reserve, using the double progression model. Participants also continue their usual diabetes care throughout. Receives: Behavioral: D-STORM Resistance Training Programme |
| Usual Care | Active comparator | Participants receive standard diabetes care in accordance with the Malaysian Clinical Practice Guidelines for Type 2 Diabetes Management (6th Edition), including general physical activity recommendations of at least 150 minutes of moderate-intensity aerobic activity per week. No structured or supervised exercise is provided. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Haemoglobin (HbA1c)
Between-group difference in HbA1c (%) from baseline to 12 weeks. The minimum clinically important difference is defined as a reduction of ≥1.0% absolute HbA1c. Measured by standardised laboratory assay at baseline (Visit 1) and post-intervention (Visit 7).
Measured: Baseline to 12 weeks
Secondary outcomes (6)
Body Composition
Segmental body composition including skeletal muscle mass, fat mass, fat-free mass, and body fat percentage measured by bioelectrical impedance analysis (InBody 270) under standardised conditions.
Measured: Baseline to 12 weeks
Functional Exercise Capacity
Assessed using the Incremental Shuttle Walk Test (ISWT), measuring the maximum distance walked under a progressively increasing pace protocol.
Measured: Baseline to 12 weeks
Blood Pressure
Systolic and diastolic blood pressure (mmHg) measured at Visits 1, 3, 5, 7, and 9.
Measured: Baseline to 12 weeks
Resting Heart Rate
Resting heart rate (bpm) measured at Visits 1, 3, 5, 7, and 9.
Measured: Baseline to 12 weeks
Health-Related Quality of Life
Assessed using the SF-36 questionnaire at baseline and post-intervention (12 weeks).
Measured: Baseline to 12 weeks
Exercise Self-Efficacy
Self-reported exercise self-efficacy measured by validated questionnaire at baseline and post-intervention (12 weeks).
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomised controlled trial. Participants are randomly allocated 1:1 to either the D-STORM resistance training programme plus usual care, or usual care alone, for 12 weeks. Randomisation is performed using a computer-generated sequence with allocation concealment via sequentially numbered sealed opaque envelopes.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhamad Faiz Bin Alias, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664501
- Sponsor's protocol ID
- 600-RMC/MOHE HICoE CARE-I 5/3
- Acronym
- D-STORM
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article will be made available after de-identification, including text, tables, figures, and appendices.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM): Rationale and Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07664501
- Acronym / sponsor ID
- D-STORM / 600-RMC/MOHE HICoE CARE-I 5/3
- Keywords
- Type 2 diabetes mellitus, Resistance training, Muscular hypertrophy, Glycaemic control, HbA1c, Cardiometabolic outcomes, Randomised controlled trial, Minimal effective dose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- 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.
Type 2 diabetes is associated with progressive loss of muscle mass, which worsens blood sugar control and increases the risk of heart disease and disability. Resistance training (weight training) has been shown to build muscle and improve blood sugar levels, but most existing programmes use high intensities that are difficult for older or inactive people with diabetes to sustain.
This study tests a new resistance training programme called D-STORM (Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population), which uses a lower, more manageable training load designed to be safe, tolerable, and effective for adults with Type 2 diabetes who are not on insulin.
Participants will be randomly assigned to either twice-weekly D-STORM training plus their usual diabetes care, or usual care alone, for 12 weeks. The main outcome measured is change in HbA1c (a blood test reflecting average blood sugar over 3 months). Body composition, walking capacity, blood pressure, heart rate, and quality of life will also be measured.
Detailed description
The D-STORM trial is a 2-arm parallel randomised controlled trial conducted at Hospital Sultan Al-Abdullah (HASA), Puncak Alam, Selangor, Malaysia. Adults aged 18 to 65 years with Type 2 diabetes mellitus (HbA1c 6.5% to 13.0%) who are not on insulin therapy will be recruited and randomly allocated 1:1 to the D-STORM intervention arm or the usual care arm.
The D-STORM programme consists of 6 compound resistance exercises performed twice weekly on non-consecutive days for 12 weeks, at 60-80% of one-repetition maximum (1RM), 2 working sets per exercise, using the double progression model with sets terminated at 1-3 repetitions in reserve (RIR).
The primary outcome is between-group difference in HbA1c (%) from baseline to 12 weeks, with a minimum clinically important difference of 1.0% absolute reduction. Secondary outcomes include body composition (bioelectrical impedance analysis; InBody 270), functional exercise capacity (Incremental Shuttle Walk Test), blood pressure, resting heart rate, and health-related quality of life (SF-36). Sample size: 124 participants (62 per arm), accounting for 10% dropout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel randomised controlled trial. Participants are randomly allocated 1:1 to either the D-STORM resistance training programme plus usual care, or usual care alone, for 12 weeks. Randomisation is performed using a computer-generated sequence with allocation concealment via sequentially numbered sealed opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| D-STORM Training plus Usual Care | Experimental | Behavioral: D-STORM Resistance Training ProgrammeParticipants perform the D-STORM resistance training programme twice weekly on non-consecutive days for 12 weeks, comprising 6 compound exercises at 60-80% 1RM, 2 working sets per exercise, terminated at 1-3 repetitions in reserve, using the double progression model. Participants also continue their usual diabetes care throughout. |
| Usual Care | Active comparator | Other: usual careParticipants receive standard diabetes care in accordance with the Malaysian Clinical Practice Guidelines for Type 2 Diabetes Management (6th Edition), including general physical activity recommendations of at least 150 minutes of moderate-intensity aerobic activity per week. No structured or supervised exercise is provided. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 65 years
- Confirmed diagnosis of Type 2 Diabetes Mellitus
- HbA1c between 6.5% and 13.0%
- Not currently on insulin therapy
- Has a primary care provider
Key exclusion criteria (8 listed)
- Age below 18 or above 65 years
- Blood pressure 160/100 mmHg or higher at screening
- HbA1c below 6.5% or above 13.0%
- Currently on insulin therapy
- Pregnant or planning to become pregnant within the next 6 months
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 |
|---|---|---|
| D-STORM Resistance Training ProgrammeTwice-weekly progressive resistance training comprising 6 compound exercises (upper body pull, upper body push, lower body push, lower body pull) at 60-80% 1RM, 2 working sets per exercise per session (minimum 4 sets per muscle group per week), 8-12 repetitions per set, terminated at 1-3 repetitions in reserve. Load is progressively increased using the double progression model. Total intervention duration is 12 weeks. | Behavioural | D-STORM Training plus Usual Care |
| usual careParticipants receive standard diabetes care in accordance with the Malaysian Clinical Practice Guidelines for Type 2 Diabetes Management (6th Edition), including general physical activity recommendations of at least 150 minutes of moderate-intensity aerobic activity per week distributed over at least 3 days, with resistance exercise on a minimum of 2 non-consecutive days per week. No structured, supervised, or progressive training is provided. | Other | Usual Care |
Primary outcome
Glycated Haemoglobin (HbA1c)
Time frame: Baseline to 12 weeks
Between-group difference in HbA1c (%) from baseline to 12 weeks. The minimum clinically important difference is defined as a reduction of ≥1.0% absolute HbA1c. Measured by standardised laboratory assay at baseline (Visit 1) and post-intervention (Visit 7).
6 secondary outcomes
Body Composition
Time frame: Baseline to 12 weeks
Functional Exercise Capacity
Time frame: Baseline to 12 weeks
Blood Pressure
Time frame: Baseline to 12 weeks
Resting Heart Rate
Time frame: Baseline to 12 weeks
Health-Related Quality of Life
Time frame: Baseline to 12 weeks
Exercise Self-Efficacy
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article will be made available after de-identification, including text, tables, figures, and appendices.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-STORM Resistance Training Programme in people with Type 2 Diabetes Mellitus (T2DM) and Sarcopenia, run by Universiti Teknologi Mara at 1 site in Malaysia.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 Jun 2026. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhamad Faiz Alias, BPT, MSc (sport science) (+60355442912, faiz.fisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Haemoglobin (HbA1c) (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.