Type 2 Diabetes Mellitus (T2DM)Phase 2PRESERVE-HMBNCT07760948
HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide
A Phase 2 study testing Calcium-HMB Plus Vitamin D3 in people with Type 2 Diabetes Mellitus (T2DM) and Sarcopenia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled trial will evaluate whether daily calcium beta-hydroxy-beta-methylbutyrate (calcium-HMB) plus vitamin D3 preserves muscle mass, physical function, and resting metabolism in adults aged 65 to 85 years with type 2 diabetes who are newly starting semaglutide as part of… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Sarcopenia, Obesity
- What is being tested?
- Calcium-HMB Plus Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to Nov 2030
- Phase
- Phase 2
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 to 85 years, inclusive.
- Type 2 diabetes mellitus, defined by HbA1c at or above 6.5% or current use of antihyperglycemic medication.
- Body mass index at or above 27 kg/m2.
- Newly initiating semaglutide as standard clinical care under the direction of a treating clinician.
- Able to walk 400 meters without assistance; use of a cane is permitted.
- Able to understand and provide legally effective informed consent.
- English speaking for the initial study because the consent documents, questionnaires, study-product instructions, safety instructions, and procedure-specific materials are available only in English.
Who cannot join
- Estimated glomerular filtration rate below 45 mL/min/1.73 m2.
- Use of HMB, creatine, or high-dose whey protein supplements within the previous 3 months.
- Weight change greater than 5% during the previous 3 months.
- Recent fracture within the previous 6 months.
- Neuromuscular disease, including Parkinson disease, or another condition that would interfere with study outcomes or safe participation.
- Chronic corticosteroid use.
Show all 15Show fewer
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
- History of pancreatitis.
- Smoking more than 7 cigarettes per day.
- Previous malabsorptive or restrictive intestinal surgery or a malabsorptive syndrome.
- Pregnancy or breastfeeding.
- Recent history of neoplasia within the previous 5 years, as defined by the protocol.
- Other active inflammatory conditions or neuromuscular disorders that could interfere with study outcomes or safety.
- Serum 25-hydroxyvitamin D below 15 ng/mL.
- Any medical, functional, laboratory, medication-related, or safety condition that the investigator determines makes study participation unsafe or prevents completion of essential procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Preserving the Metabolic Engine: Effects of HMB Supplementation on Skeletal Muscle Structure and Function During Semaglutide-Associated Weight Loss in Older Adults
This randomized, double-blind, placebo-controlled trial will evaluate whether daily calcium beta-hydroxy-beta-methylbutyrate (calcium-HMB) plus vitamin D3 preserves muscle mass, physical function, and resting metabolism in adults aged 65 to 85 years with type 2 diabetes who are newly starting semaglutide as part of usual clinical care. Participants will receive calcium-HMB plus vitamin D3 or matching placebo for approximately 6 months. The primary outcome is change in appendicular lean mass measured by dual-energy X-ray absorptiometry from baseline to month 6. Secondary assessments include body composition, muscle strength, physical performance, gait, physical activity, resting metabolic rate, metabolic measures, and whole-body quantitative computed tomography. An optional mechanistic substudy of up to 36 participants will include D3-creatine dilution, nonradioactive stable isotope infusions, repeated blood sampling, a standardized meal, breath sampling, and vastus lateralis muscle biopsies at baseline and month 6.
Read the detailed description
Semaglutide treatment can produce substantial weight loss and improve glycemic control, but some weight loss may be accompanied by loss of lean tissue and skeletal muscle. Older adults with type 2 diabetes may be particularly vulnerable to loss of muscle mass, strength, mobility, and physical independence. Metabolic adaptation, defined as a reduction in resting metabolic rate beyond that expected from changes in body composition, may also occur during rapid weight loss.
Calcium-HMB is a leucine metabolite with anabolic and anti-catabolic properties. This study will test whether supplementation with calcium-HMB plus vitamin D3 during the first 6 months of standard-of-care semaglutide therapy preserves appendicular lean mass and improves physical and metabolic outcomes compared with placebo. Semaglutide is prescribed and managed by each participant's treating clinician and is not assigned, supplied, or managed by the research study.
Participants will be randomized 1:1, stratified by sex, to active study product or matching placebo. The active intervention provides 3 g calcium-HMB and 800 IU vitamin D3 daily. Main-study assessments occur at baseline, month 3, and month 6. Baseline and month 6 assessments include whole-body DXA, noncontrast whole-body quantitative CT, resting indirect calorimetry, blood and urine collection, strength and physical-function testing, gait assessment, questionnaires, and physical-activity assessment. Month 3 includes interval safety, adherence, medication, anthropometric, questionnaire, urine, and physical-function assessments as specified by the protocol.
Up to 36 participants, targeted as 18 per randomized group, may join optional Aim 3. Aim 3 includes D3-creatine dosing with timed urine collection, an overnight Clinical Research Center stay, two peripheral intravenous catheters, nonradioactive L-[ring-13C6]phenylalanine and Nτ-[2H3]-3-methylhistidine infusions, serial blood and breath sampling, a standardized meal, and three vastus lateralis muscle-biopsy time points during each baseline and month 6 metabolic visit. Aim 3 evaluates contractile muscle mass and muscle protein synthesis and breakdown. Blood collected in the main study also supports peripheral blood mononuclear cell isolation and ancillary immune analyses.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Sarcopenia, Obesity, Muscle Loss, Older Adults
- Being tested
- Calcium-HMB Plus Vitamin D3, Matching placebo
- Keywords
- semaglutide, GLP-1 receptor agonist, beta-hydroxy-beta-methylbutyrate, HMB, calcium-HMB, vitamin D3, appendicular lean mass, metabolic adaptation, resting metabolic rate, skeletal muscle, older adults, D3-creatine, muscle protein synthesis, muscle protein breakdown
- Medical subject headings
- Diabetes Mellitus, Type 2, Sarcopenia, Obesity, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium-HMB Plus Vitamin D3Dietary supplement
Also called CaHMB plus vitamin D3, beta-hydroxy-beta-methylbutyrate plus vitamin D3, HMB plus vitamin D3
Each active capsule contains 750 mg calcium-HMB and 200 IU vitamin D3. Participants take two capsules twice daily, providing 3 g calcium-HMB and 800 IU vitamin D3 per day, for approximately 6 months.
Matching placeboOther
Participants take two matching placebo capsules twice daily for approximately 6 months. Placebo capsules are matched to active product in appearance, packaging, labeling, and dosing schedule. Insert the final placebo ingredients if the PRS administrator requests them.
| Study group | Role | What they receive |
|---|---|---|
| Calcium-HMB Plus Vitamin D3 | Experimental | Participants receive active calcium-HMB plus vitamin D3 for approximately 6 months while semaglutide is prescribed and managed as standard clinical care. Receives: Dietary Supplement: Calcium-HMB Plus Vitamin D3 |
| Matching Placebo | Placebo comparator | Participants receive matching placebo for approximately 6 months while semaglutide is prescribed and managed as standard clinical care. Receives: Other: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Appendicular Lean Mass
Appendicular lean mass will be measured by whole-body dual-energy X-ray absorptiometry. The outcome is the month-6 value minus the baseline value, reported in kilograms.
Measured: Baseline to month 6
Secondary outcomes (22)
Title Change in Body Weight
Body weight measured using a calibrated scale; change calculated as month 6 minus baseline, in kilograms.
Measured: Baseline to month 6
Change in Total Fat Mass
Total fat mass measured by whole-body DXA; change calculated as month 6 minus baseline, in kilograms.
Measured: Baseline to month 6
Title Change in Visceral Adipose Tissue
Visceral adipose tissue measured using the protocol-specified DXA or CT-derived measure. Enter the final metric and units used by the imaging analysis plan.
Measured: Baseline to month 6
Change in Bone Mineral Density
Bone mineral density measured by DXA and/or quantitative CT at protocol-specified skeletal sites. Enter the final site-specific metric and units.
Measured: Baseline to month 6
Change in Trabecular Bone Score
Trabecular bone score derived from DXA; change calculated as month 6 minus baseline.
Measured: Baseline to month 6
Change in Glycated Hemoglobin
HbA1c measured from blood samples; change calculated as month 6 minus baseline, in percent.
Measured: Time Frame Baseline to month 6
Change in Fasting Plasma Glucose
Fasting plasma glucose measured from blood samples; change calculated as month 6 minus baseline, in mg/dL.
Measured: Baseline to month 6
Change in Resting Metabolic Rate
Resting metabolic rate measured by indirect calorimetry; change calculated as month 6 minus baseline, in kcal/day.
Measured: Baseline to month 6
Change in Handgrip Strength
Maximum handgrip strength measured by dynamometry; change from baseline. Enter the final hand and aggregation rule, such as maximum of trials, and units in kilograms or newtons.
Measured: Baseline, month 3, and month 6
Title Change in Lower-Extremity Strength or Torque
Lower-extremity strength or torque measured using Biodex or other protocol-approved equipment. Enter the final movement, velocity, summary metric, and units.
Measured: Baseline to month 6
Title Change in Short Physical Performance Battery Score
Short Physical Performance Battery total score, range 0 to 12, with higher scores indicating better lower-extremity physical performance.
Measured: Baseline, month 3, and month 6
Change in Six-Minute Walk Distance
Distance walked during the six-minute walk test, in meters.
Measured: Baseline, month 3, and month 6
Change in Gait Measures
Gait assessed using wearable inertial sensors. Enter each prespecified gait metric as a separate outcome if inferential testing is planned, including the metric name and units.
Measured: Baseline, month 3, and month 6
Change in Physical Activity
Physical activity measured by accelerometer or wearable activity monitor. Enter each prespecified analytic variable, such as steps/day or minutes/day of moderate-to-vigorous activity, as a separate outcome
Measured: Protocol-defined monitoring periods at baseline or month 3 and month 6
Change in Whole-Body CT-Derived Muscle Volume and Composition
Noncontrast whole-body quantitative CT will measure muscle volume and composition. Enter each prespecified CT metric and units as a separate outcome.
Measured: Baseline to month 6
Change in Total Body Creatine Pool Size
Among optional Aim 3 participants, D3-creatine dilution will estimate total body creatine pool size and derived contractile muscle mass. Enter the final units used by the analytic laboratory.
Measured: Baseline to month 6
Change in Myofibrillar Protein Synthesis
Description Among optional Aim 3 participants, myofibrillar fractional synthesis rate will be derived from L-[ring-13C6]phenylalanine tracer enrichment and muscle-biopsy measurements. Enter the final expression, expected to be percent per hour.
Measured: Baseline and month 6 Aim 3 metabolic visits
Change in Muscle Protein Breakdown
Among optional Aim 3 participants, muscle protein breakdown will be estimated using Nτ-[2H3]-3-methylhistidine tracer kinetics. Enter the final kinetic measure and units.
Measured: Baseline and month 6 Aim 3 metabolic visits
Change in Net Muscle Protein Balance
Among optional Aim 3 participants, net protein balance will be derived from protocol-specified synthesis and breakdown measurements. Enter the final calculation and units.
Measured: Baseline and month 6 Aim 3 metabolic visits
Change in Muscle Fiber Size and Type
Among optional Aim 3 participants, vastus lateralis biopsy specimens will be analyzed for muscle-fiber cross-sectional area and fiber-type distribution. Enter cross-sectional area and fiber-type outcomes separately with units.
Measured: Baseline to month 6
Study-Product Adherence
Adherence assessed by returned-product count, participant report, and protocol-specified HMB measurements. Report the prespecified primary adherence metric, such as percentage of expected doses taken.
Measured: Through month 6
Incidence of Adverse Events
Number and percentage of participants experiencing adverse events and serious adverse events, summarized by treatment group, severity, seriousness, expectedness, and relationship.
Measured: From first study-product dose through completion of month-6 follow-up or resolution/stabilization of ongoing events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned 1:1, with stratification by sex, to calcium-HMB plus vitamin D3 or matching placebo for approximately 6 months while receiving semaglutide as standard clinical care.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Charles R. Flynn, Vanderbilt University Medical Center
- Investigators
- Robb Flynn, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760948
- Sponsor's protocol ID
- 261081
- Other IDs
- 9-26-ICTS-1434
- Acronym
- PRESERVE-HMB
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant-level data underlying reported results may be shared through a controlled-access repository, including the NIDDK Central Repository or Vivli, as permitted by informed consent, HIPAA authorization, IRB approval, repository requirements, and institutional agreements. Direct identifiers will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preserving the Metabolic Engine: Effects of HMB Supplementation on Skeletal Muscle Structure and Function During Semaglutide-Associated Weight Loss in Older Adults
- ClinicalTrials.gov ID
- NCT07760948
- Acronym / sponsor ID
- PRESERVE-HMB / 261081
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Sarcopenia, Obesity, Muscle Loss, Older Adults
- Keywords
- semaglutide, GLP-1 receptor agonist, beta-hydroxy-beta-methylbutyrate, HMB, calcium-HMB, vitamin D3, appendicular lean mass, metabolic adaptation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 12 Aug 2026 (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.
This randomized, double-blind, placebo-controlled trial will evaluate whether daily calcium beta-hydroxy-beta-methylbutyrate (calcium-HMB) plus vitamin D3 preserves muscle mass, physical function, and resting metabolism in adults aged 65 to 85 years with type 2 diabetes who are newly starting semaglutide as part of usual clinical care. Participants will receive calcium-HMB plus vitamin D3 or matching placebo for approximately 6 months. The primary outcome is change in appendicular lean mass measured by dual-energy X-ray absorptiometry from baseline to month 6. Secondary assessments include body composition, muscle strength, physical performance, gait, physical activity, resting metabolic rate, metabolic measures, and whole-body quantitative computed tomography. An optional mechanistic substudy of up to 36 participants will include D3-creatine dilution, nonradioactive stable isotope infusions, repeated blood sampling, a standardized meal, breath sampling, and vastus lateralis muscle biopsies at baseline and month 6.
Detailed description
Semaglutide treatment can produce substantial weight loss and improve glycemic control, but some weight loss may be accompanied by loss of lean tissue and skeletal muscle. Older adults with type 2 diabetes may be particularly vulnerable to loss of muscle mass, strength, mobility, and physical independence. Metabolic adaptation, defined as a reduction in resting metabolic rate beyond that expected from changes in body composition, may also occur during rapid weight loss.
Calcium-HMB is a leucine metabolite with anabolic and anti-catabolic properties. This study will test whether supplementation with calcium-HMB plus vitamin D3 during the first 6 months of standard-of-care semaglutide therapy preserves appendicular lean mass and improves physical and metabolic outcomes compared with placebo. Semaglutide is prescribed and managed by each participant's treating clinician and is not assigned, supplied, or managed by the research study.
Participants will be randomized 1:1, stratified by sex, to active study product or matching placebo. The active intervention provides 3 g calcium-HMB and 800 IU vitamin D3 daily. Main-study assessments occur at baseline, month 3, and month 6. Baseline and month 6 assessments include whole-body DXA, noncontrast whole-body quantitative CT, resting indirect calorimetry, blood and urine collection, strength and physical-function testing, gait assessment, questionnaires, and physical-activity assessment. Month 3 includes interval safety, adherence, medication, anthropometric, questionnaire, urine, and physical-function assessments as specified by the protocol.
Up to 36 participants, targeted as 18 per randomized group, may join optional Aim 3. Aim 3 includes D3-creatine dosing with timed urine collection, an overnight Clinical Research Center stay, two peripheral intravenous catheters, nonradioactive L-[ring-13C6]phenylalanine and Nτ-[2H3]-3-methylhistidine infusions, serial blood and breath sampling, a standardized meal, and three vastus lateralis muscle-biopsy time points during each baseline and month 6 metabolic visit. Aim 3 evaluates contractile muscle mass and muscle protein synthesis and breakdown. Blood collected in the main study also supports peripheral blood mononuclear cell isolation and ancillary immune analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned 1:1, with stratification by sex, to calcium-HMB plus vitamin D3 or matching placebo for approximately 6 months while receiving semaglutide as standard clinical care.
| Arm | Type | Receives |
|---|---|---|
| Calcium-HMB Plus Vitamin D3 | Experimental | Dietary Supplement: Calcium-HMB Plus Vitamin D3Participants receive active calcium-HMB plus vitamin D3 for approximately 6 months while semaglutide is prescribed and managed as standard clinical care. |
| Matching Placebo | Placebo comparator | Other: Matching placeboParticipants receive matching placebo for approximately 6 months while semaglutide is prescribed and managed as standard clinical care. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65 to 85 years, inclusive.
- Type 2 diabetes mellitus, defined by HbA1c at or above 6.5% or current use of antihyperglycemic medication.
- Body mass index at or above 27 kg/m2.
- Newly initiating semaglutide as standard clinical care under the direction of a treating clinician.
- Able to walk 400 meters without assistance; use of a cane is permitted.
Key exclusion criteria (15 listed)
- Estimated glomerular filtration rate below 45 mL/min/1.73 m2.
- Use of HMB, creatine, or high-dose whey protein supplements within the previous 3 months.
- Weight change greater than 5% during the previous 3 months.
- Recent fracture within the previous 6 months.
- Neuromuscular disease, including Parkinson disease, or another condition that would interfere with study outcomes or safe participation.
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 |
|---|---|---|
| Calcium-HMB Plus Vitamin D3Also: CaHMB plus vitamin D3, beta-hydroxy-beta-methylbutyrate plus vitamin D3, HMB plus vitamin D3Each active capsule contains 750 mg calcium-HMB and 200 IU vitamin D3. Participants take two capsules twice daily, providing 3 g calcium-HMB and 800 IU vitamin D3 per day, for approximately 6 months. | Dietary supplement | Calcium-HMB Plus Vitamin D3 |
| Matching placeboParticipants take two matching placebo capsules twice daily for approximately 6 months. Placebo capsules are matched to active product in appearance, packaging, labeling, and dosing schedule. Insert the final placebo ingredients if the PRS administrator requests them. | Other | Matching Placebo |
Primary outcome
Change in Appendicular Lean Mass
Time frame: Baseline to month 6
Appendicular lean mass will be measured by whole-body dual-energy X-ray absorptiometry. The outcome is the month-6 value minus the baseline value, reported in kilograms.
22 secondary outcomes
Title Change in Body Weight
Time frame: Baseline to month 6
Change in Total Fat Mass
Time frame: Baseline to month 6
Title Change in Visceral Adipose Tissue
Time frame: Baseline to month 6
Change in Bone Mineral Density
Time frame: Baseline to month 6
Change in Trabecular Bone Score
Time frame: Baseline to month 6
Change in Glycated Hemoglobin
Time frame: Time Frame Baseline to month 6
Change in Fasting Plasma Glucose
Time frame: Baseline to month 6
Change in Resting Metabolic Rate
Time frame: Baseline to month 6
Change in Handgrip Strength
Time frame: Baseline, month 3, and month 6
Title Change in Lower-Extremity Strength or Torque
Time frame: Baseline to month 6
Title Change in Short Physical Performance Battery Score
Time frame: Baseline, month 3, and month 6
Change in Six-Minute Walk Distance
Time frame: Baseline, month 3, and month 6
Change in Gait Measures
Time frame: Baseline, month 3, and month 6
Change in Physical Activity
Time frame: Protocol-defined monitoring periods at baseline or month 3 and month 6
Change in Whole-Body CT-Derived Muscle Volume and Composition
Time frame: Baseline to month 6
Change in Total Body Creatine Pool Size
Time frame: Baseline to month 6
Change in Myofibrillar Protein Synthesis
Time frame: Baseline and month 6 Aim 3 metabolic visits
Change in Muscle Protein Breakdown
Time frame: Baseline and month 6 Aim 3 metabolic visits
Change in Net Muscle Protein Balance
Time frame: Baseline and month 6 Aim 3 metabolic visits
Change in Muscle Fiber Size and Type
Time frame: Baseline to month 6
Study-Product Adherence
Time frame: Through month 6
Incidence of Adverse Events
Time frame: From first study-product dose through completion of month-6 follow-up or resolution/stabilization of ongoing events
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 28 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified participant-level data underlying reported results may be shared through a controlled-access repository, including the NIDDK Central Repository or Vivli, as permitted by informed consent, HIPAA authorization, IRB approval, repository requirements, and institutional agreements. Direct identifiers will not be shared.
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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.
Robb Flynn, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium-HMB Plus Vitamin D3 in people with Type 2 Diabetes Mellitus (T2DM) and Sarcopenia, run by Vanderbilt University Medical Center at 1 site in United States.
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 7 inclusion and 15 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Robb Flynn, PhD (615-342-8329, robb.flynn@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Appendicular Lean Mass (time frame: Baseline to month 6). 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 28 Aug 2026.