Exercise and/or HMB in Older Diabetes With Low Muscle Mass
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HMB, Exercise, Placebo, Education.
- Who it may be relevant to
- Registry conditions: Diabetes, Low Muscle Mass. Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Exercise and/or β-hydroxy-β-methylbutyrate Supplementation on Muscle Mass, Physical Performance and Insulin Resistance in Older Diabetes With Low Muscle Mass: a Randomized, Double-blind, Placebo-controlled Trial
Overview
The investigators aimed to examine if β-hydroxy-β-methylbutyrate (HMB) supplementation enhances the effects of exercise on muscle mass, physical performance and insulin resistance and observe potential residual effects in older diabetes with low muscle mass, and to find the optimal treatment plan.
Detailed description
The interaction between exercise and nutritional supplementation is unclear among older diabetes at risk of sarcopenia. The investigators aimed to examine if β-hydroxy-β-methylbutyrate (HMB) supplementation enhances the effects of exercise on muscle mass, physical performance and insulin resistance and observe potential residual effects in older diabetes with low muscle mass, and to find the optimal treatment plan. This 12-wk, randomized, double-blind, placebo controlled, 2 × 2 factorial design (exercise-only, HMB-only, both, and none) trial included 120 older diabetes aged 60-80 y with skeletal muscle index \<5.7 kg/m2 for women, and \<7.0 kg/m2 for men, and was followed by a 12-wk observational period.
Interventions
- Dietary supplement HMB
Participants were instructed to take active products including 3000 mg calcium-HMB per day - Behavioral Exercise
Participants allocated to the exercise programs were provided 45 min of supervised sessions on 2 nonconsecutive days per week - Dietary supplement Placebo
Participants were instructed to take active products including equal in quality resistant dextrin per day - Other Education
Participants were given health education and educational manuals
Primary outcome measures
- muscle mass [Time frame: 0 and 12 weeks]
- Handgrip strength [Time frame: 0 and 12 weeks]
- 5-repetition sit-to-stand time [Time frame: 0 and 12 weeks]
Secondary outcome measures (1)
- insulin resistance index [Time frame: 0 and 12 weeks]
Eligibility criteria
Inclusion criteria
- Aged 60-80 ;
- Diagnosis of T2DM
- Low muscle mass: met a reference value for low muscle mass defined by the Asian Working Group for Sarcopenia (AWGS) criteria with skeletal muscle index <5.7 kg/m2 for women and <7.0 kg/m2 for men
Exclusion criteria
- Individuals who had an organic disease of the nervous system;
- Who were restricted from engaging in exercise by a medical doctor;
- Who was unconscious and unable to complete the questionnaire;
- Who used other supplementations for muscle mass gain;
- Who had impaired cardiac, kidney, or liver function.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07142941 · exercise and/or HMB