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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07142941
Enrollment
120
Registered
2025-08-27
Start date
2026-04-01
Completion date
2027-12-31
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Low Muscle Mass

Keywords

low muscle mass, diabetes, HMB, exercise

Brief summary

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_SUPPLEMENTHMB

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

BEHAVIORALExercise

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

DIETARY_SUPPLEMENTPlacebo

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

OTHEREducation

Participants were given health education and educational manuals

Sponsors

Wu Shangling
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
muscle mass0 and 12 weeksBody composition including muscle mass was measured using a segmental multifrequency bioelectrical impedance device (Inbody)
Handgrip strength0 and 12 weeksHandgrip strength was measured using a handheld Smedley-type dynamometer.
5-repetition sit-to-stand time0 and 12 weeksParticipants 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

MeasureTime frameDescription
insulin resistance index0 and 12 weeksHomeostatic Model Assessment for Insulin Resistance (HOMA-IR) was calculated as follow: HOMA-IR=(Fasting Insulin (μU/mL)×Fasting Glucose (mg/dL))/405

Contacts

CONTACTShangling Wu
wushling6@mail.sysu.edu.cn(020)87338179
STUDY_CHAIRShangling Wu

First Affiliated Hospital, Sun Yat-Sen University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026