Insulin Resistance, Sarcopenia, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Type 2 diabetes mellitus, Resistance training, Muscular hypertrophy, Glycaemic control, HbA1c, Cardiometabolic outcomes, Randomised controlled trial, Minimal effective dose
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.
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.
Interventions
BEHAVIORALD-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.
OTHERusual 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.
Sponsors
Universiti Teknologi Mara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Haemoglobin (HbA1c) | 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
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | 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. |
| Functional Exercise Capacity | Baseline to 12 weeks | Assessed using the Incremental Shuttle Walk Test (ISWT), measuring the maximum distance walked under a progressively increasing pace protocol. |
| Blood Pressure | Baseline to 12 weeks | Systolic and diastolic blood pressure (mmHg) measured at Visits 1, 3, 5, 7, and 9. |
| Resting Heart Rate | Baseline to 12 weeks | Resting heart rate (bpm) measured at Visits 1, 3, 5, 7, and 9. |
| Health-Related Quality of Life | Baseline to 12 weeks | Assessed using the SF-36 questionnaire at baseline and post-intervention (12 weeks). |
| Exercise Self-Efficacy | Baseline to 12 weeks | Self-reported exercise self-efficacy measured by validated questionnaire at baseline and post-intervention (12 weeks). |
Countries
Malaysia
Contacts
CONTACTMuhamad Faiz Alias, BPT, MSc (sport science)
Outcome results
None listed