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NCT Number: NCT07142941

Exercise and/or HMB in Older Diabetes With Low Muscle Mass

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

HMB

Dietary Supplement

Participants were instructed to take active products including 3000 mg calcium-HMB per day

Exercise

Behavioral

Participants allocated to the exercise programs were provided 45 min of supervised sessions on 2 nonconsecutive days per week

Placebo

Dietary Supplement

Participants were instructed to take active products including equal in quality resistant dextrin per day

Education

Other

Participants were given health education and educational manuals

Primary outcomes

  1. muscle mass

    Time frame: 0 and 12 weeks

    Body composition including muscle mass was measured using a segmental multifrequency bioelectrical impedance device (Inbody)

  2. Handgrip strength

    Time frame: 0 and 12 weeks

    Handgrip strength was measured using a handheld Smedley-type dynamometer.

  3. 5-repetition sit-to-stand time

    Time frame: 0 and 12 weeks

    Participants folded their arms across their chests and were instructed to stand-up completely and make firm contact when sitting. Timing began on the command "go" and ceased when the participants sat after the fifth stand-up. Participants were allowed a practice trial of 2 repetitions before the timing of 2 test trials of 5 repetitions.

Secondary outcomes

  1. insulin resistance index

    Time frame: 0 and 12 weeks

    Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) was calculated as follow:

    HOMA-IR=(Fasting Insulin (μU/mL)×Fasting Glucose (mg/dL))/405

Study contacts

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

Shangling Wu

CONTACT

[email protected]

(020)87338179

Sponsors and collaborators

Lead sponsor

Wu Shangling

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Mar 31, 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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