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NCT07664501
The Simplified Total-body Resistance Exercise for Muscular Hypertrophy for Diabetic Population (D-STORM): Rationale and Study Protocol for a Randomized Controlled Trial
Conditions: Type 2 Diabetes Mellitus (T2DM), Sarcopenia, Insulin Resistance
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 56
Sponsor: Universiti Teknologi Mara
Location: Hospital Sultan Al-Abdullah (HASA) Kuala Selangor Selangor
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07664501). StuddyBuddy aggregates publicly available trial information.