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

NCT07664501 | Not Yet Recruiting

• 1 other identifier: 600-RMC/MOHE HICoE CARE-I 5/3
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Sarcopenia; Insulin Resistance

Keywords

Type 2 diabetes mellitus; Resistance training; Muscular hypertrophy; Glycaemic control; HbA1c; Cardiometabolic outcomes; Randomised controlled trial; Minimal effective dose

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline to 12 weeks

Secondary Outcomes (6)

• Body Composition

  Baseline to 12 weeks

• Functional Exercise Capacity

  Baseline to 12 weeks

• Blood Pressure

  Baseline to 12 weeks

• Resting Heart Rate

  Baseline to 12 weeks

• Health-Related Quality of Life

  Baseline to 12 weeks

Study Arms (2)

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.

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.

Other: usual care

Interventions

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.

D-STORM Training plus Usual Care

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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Teknologi Mara: lead

Study Sites (1)

Hospital Sultan Al-Abdullah (HASA)

Kuala Selangor, Selangor, 42300, Malaysia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sarcopenia; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hyperinsulinism

Central Study Contacts

Muhamad Faiz Alias, BPT, MSc (sport science)

CONTACT

+60355442912; faiz.fisio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not applicable in this study. Due to the nature of the exercise intervention, participants and the treating physiotherapist can readily distinguish group allocation. The study is therefore conducted as an open-label trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication, for a period of 5 years.
• 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.

Locations

MY (1)