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

NCT ID: NCT07142941

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-31

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.

Conditions

Diabetes; Low Muscle Mass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HMB + Exercise

Participants were instructed to take active products including 3000 mg calcium-HMB per day, and allocated to the exercise programs were provided 45 min of supervised sessions on 2 nonconsecutive days per week

Group Type: EXPERIMENTAL

HMB

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise

Intervention Type: BEHAVIORAL

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

Placebo + Exercise

Participants allocated to the exercise programs were provided 45 min of supervised sessions on 2 nonconsecutive days per week, and were instructed to take active products including equal in quality resistant dextrin per day

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

HMB + Education

Participants were instructed to take active products including 3000 mg calcium-HMB per day, and were given health education and educational manuals.

Group Type: EXPERIMENTAL

HMB

Intervention Type: DIETARY_SUPPLEMENT

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

Education

Intervention Type: OTHER

Participants were given health education and educational manuals

Placebo + Education

Participants were instructed to take active products including equal in quality resistant dextrin per day, and were given health education and educational manuals

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Education

Intervention Type: OTHER

Participants were given health education and educational manuals

Interventions

HMB

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

Intervention Type: DIETARY_SUPPLEMENT

Exercise

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

Intervention Type: BEHAVIORAL

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Education

Participants were given health education and educational manuals

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wu Shangling

OTHER

Sponsor Role: lead

Responsible Party

Wu Shangling

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shangling Wu

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Central Contacts

Shangling Wu

Role: CONTACT

wushling6@mail.sysu.edu.cn

(020)87338179

Other Identifiers

exercise and/or HMB

Identifier Type: -

Identifier Source: org_study_id