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

March 30, 2026 updated by: Wu Shangling

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Experimental: 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
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
Experimental: HMB + Education
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
Participants were instructed to take active products including 3000 mg calcium-HMB per day
Other: Education
Participants were given health education and educational manuals
Placebo Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle mass
Time Frame: 0 and 12 weeks
Body composition including muscle mass was measured using a segmental multifrequency bioelectrical impedance device (Inbody)
0 and 12 weeks
Handgrip strength
Time Frame: 0 and 12 weeks
Handgrip strength was measured using a handheld Smedley-type dynamometer.
0 and 12 weeks
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.
0 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wu Shangling

Investigators

  • Study Chair: Shangling Wu, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 25, 2025

First Submitted That Met QC Criteria

August 26, 2025

First Posted (Actual)

August 27, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • exercise and/or HMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on HMB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe