The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM) (D-STORM)

June 22, 2026 updated by: Muhamad Faiz Bin Alias, Universiti Teknologi Mara

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Muhamad Faiz Alias, BPT, MSc (sport science)
  • Phone Number: +60355442912
  • Email: faiz.fisio@gmail.com

Study Locations

  • Malaysia
    • Selangor
      • Kuala Selangor, Selangor, Malaysia, 42300
        • Hospital Sultan Al-Abdullah (HASA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D-STORM Training plus Usual Care
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.
Behavioral: D-STORM Resistance Training Programme
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.
Active Comparator: Usual Care
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.
Other: usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: Baseline to 12 weeks
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.
Baseline to 12 weeks
Functional Exercise Capacity
Time Frame: Baseline to 12 weeks
Assessed using the Incremental Shuttle Walk Test (ISWT), measuring the maximum distance walked under a progressively increasing pace protocol.
Baseline to 12 weeks
Blood Pressure
Time Frame: Baseline to 12 weeks
Systolic and diastolic blood pressure (mmHg) measured at Visits 1, 3, 5, 7, and 9.
Baseline to 12 weeks
Resting Heart Rate
Time Frame: Baseline to 12 weeks
Resting heart rate (bpm) measured at Visits 1, 3, 5, 7, and 9.
Baseline to 12 weeks
Health-Related Quality of Life
Time Frame: Baseline to 12 weeks
Assessed using the SF-36 questionnaire at baseline and post-intervention (12 weeks).
Baseline to 12 weeks
Exercise Self-Efficacy
Time Frame: Baseline to 12 weeks
Self-reported exercise self-efficacy measured by validated questionnaire at baseline and post-intervention (12 weeks).
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Teknologi Mara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 600-RMC/MOHE HICoE CARE-I 5/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 6 months after publication, for a period of 5 years.

IPD Sharing Access Criteria

Data will be shared with researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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