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NCT Number: NCT07664501

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Atrophy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sultan Al-Abdullah (HASA)

Kuala Selangor, Selangor, 42300, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-STORM Resistance Training Programme

Behavioral

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 Care

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. Blood Pressure

    Time frame: Baseline to 12 weeks

    Systolic and diastolic blood pressure (mmHg) measured at Visits 1, 3, 5, 7, and 9.

  4. Resting Heart Rate

    Time frame: Baseline to 12 weeks

    Resting heart rate (bpm) measured at Visits 1, 3, 5, 7, and 9.

  5. Health-Related Quality of Life

    Time frame: Baseline to 12 weeks

    Assessed using the SF-36 questionnaire at baseline and post-intervention (12 weeks).

  6. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Muhamad Faiz Alias, BPT, MSc (sport science)

CONTACT

[email protected]

+60355442912

Sponsors and collaborators

Lead sponsor

Universiti Teknologi Mara

Other

Registry information

Official study title

The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM): Rationale and Study Protocol for a Randomized Controlled Trial

Acronym: D-STORM

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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