DiabetesNCT07142941
Exercise and/or HMB in Older Diabetes With Low Muscle Mass
A study testing HMB, Exercise and Education in people with Diabetes and Low Muscle Mass, run by Wu Shangling.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Diabetes, Low Muscle Mass
- What is being tested?
- HMB, Exercise and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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
- Being tested
- HMB, Exercise, Placebo, Education
- Keywords
- low muscle mass, diabetes, HMB, exercise
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMBDietary supplement
Participants were instructed to take active products including 3000 mg calcium-HMB per day
ExerciseBehavioural
Participants allocated to the exercise programs were provided 45 min of supervised sessions on 2 nonconsecutive days per week
PlaceboDietary supplement
Participants were instructed to take active products including equal in quality resistant dextrin per day
EducationOther
Participants were given health education and educational manuals
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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 Receives: Dietary Supplement: Placebo; Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass
Body composition including muscle mass was measured using a segmental multifrequency bioelectrical impedance device (Inbody)
Measured: 0 and 12 weeks
Handgrip strength
Handgrip strength was measured using a handheld Smedley-type dynamometer.
Measured: 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.
Measured: 0 and 12 weeks
Secondary outcomes (1)
insulin resistance index
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) was calculated as follow:
HOMA-IR=(Fasting Insulin (μU/mL)×Fasting Glucose (mg/dL))/405
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wu Shangling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wu Shangling, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Shangling Wu, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142941
- Sponsor's protocol ID
- exercise and/or HMB
- Status last verified
- Mar 2026
- First submitted
- 25 Jul 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07142941
- Acronym / sponsor ID
- exercise and/or HMB
- Conditions
- Diabetes, Low Muscle Mass
- Keywords
- low muscle mass, diabetes, HMB, exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wu ShanglingUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HMB + Exercise | Experimental | Dietary Supplement: HMB, Behavioral: ExerciseParticipants 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 |
| Placebo + Exercise | Experimental | Behavioral: Exercise, Dietary Supplement: PlaceboParticipants 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 |
| HMB + Education | Experimental | Dietary Supplement: HMB, Other: EducationParticipants were instructed to take active products including 3000 mg calcium-HMB per day, and were given health education and educational manuals. |
| Placebo + Education | Placebo comparator | Dietary Supplement: Placebo, Other: EducationParticipants were instructed to take active products including equal in quality resistant dextrin per day, and were given health education and educational manuals |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMBParticipants were instructed to take active products including 3000 mg calcium-HMB per day | Dietary supplement | HMB + Education, HMB + Exercise |
| ExerciseParticipants allocated to the exercise programs were provided 45 min of supervised sessions on 2 nonconsecutive days per week | Behavioural | HMB + Exercise, Placebo + Exercise |
| PlaceboParticipants were instructed to take active products including equal in quality resistant dextrin per day | Dietary supplement | Placebo + Education, Placebo + Exercise |
| EducationParticipants were given health education and educational manuals | Other | HMB + Education, Placebo + Education |
Primary outcome
muscle mass
Time frame: 0 and 12 weeks
Body composition including muscle mass was measured using a segmental multifrequency bioelectrical impedance device (Inbody)
Handgrip strength
Time frame: 0 and 12 weeks
Handgrip strength was measured using a handheld Smedley-type dynamometer.
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.
1 secondary outcome
insulin resistance index
Time frame: 0 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shangling Wu study chair
First Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A study testing HMB, Exercise and Education in people with Diabetes and Low Muscle Mass, run by Wu Shangling.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shangling Wu ((020)87338179, wushling6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle mass (time frame: 0 and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.