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

NCT07142941 | Not Yet Recruiting DMC

• 1 other identifier: exercise and/or HMB
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes; Low Muscle Mass

Keywords

low muscle mass; diabetes; HMB; exercise

Outcome Measures

Primary Outcomes (3)

• muscle mass

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

  0 and 12 weeks

• Handgrip strength

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

  0 and 12 weeks

• 5-repetition sit-to-stand time

  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.

  0 and 12 weeks

Secondary Outcomes (1)

• insulin resistance index

  0 and 12 weeks

Study Arms (4)

HMB + Exercise

EXPERIMENTAL

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

Dietary Supplement: HMB; Behavioral: Exercise

Placebo + Exercise

EXPERIMENTAL

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

Behavioral: Exercise; Dietary Supplement: Placebo

HMB + Education

EXPERIMENTAL

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

Dietary Supplement: HMB; Other: Education

Placebo + Education

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo; Other: Education

Interventions

HMB DIETARY_SUPPLEMENT

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

HMB + Education; HMB + Exercise

Exercise BEHAVIORAL

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

HMB + Exercise; Placebo + Exercise

Placebo DIETARY_SUPPLEMENT

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

Placebo + Education; Placebo + Exercise

Education OTHER

Participants were given health education and educational manuals

HMB + Education; Placebo + Education

Eligibility Criteria

• Age: 60 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wu Shangling: lead

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Shangling Wu

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Shangling Wu

CONTACT

(020)87338179; wushling6@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 27, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share