A Phase 2 interventional study of Calcium-HMB Plus Vitamin D3 and Matching placebo in Type 2 Diabetes Mellitus (T2DM), Sarcopenia and Obesity, sponsored by Vanderbilt University Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Vanderbilt University Medical Center · Phase 2, Interventional, and Prevention
Among 21 studies in Diabetes Mellitus, Type 2 by Vanderbilt University Medical Center — 4 open to participants now, 5 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Vanderbilt University Medical Center.
Among the 21 studies in Diabetes Mellitus, Type 2 by Vanderbilt University Medical Center, this one is the 10th largest by planned enrollment of the 18 interventional ones that give a count, is the only one that started in 2026, is the only one in phase 2, and was the 21st registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →4 of the 21 studies in Diabetes Mellitus, Type 2 by Vanderbilt University Medical Center are open now, in 1 country. Recruiting first, the newest first:
Vanderbilt University Medical Center · Sites in United States
Vanderbilt University Medical Center · Sites in United States
Vanderbilt University Medical Center · Sites in United States
By country, each count listing its studies:
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 65 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 1
First in 2007; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 90 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 135 across the 18 interventional studies, 172 across the 3 observational. Of the 15 that completed or were terminated, 11 (73%) have results posted.
This tab as a report to print or save as PDF → With an account.
Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
2 of the studies in Diabetes Mellitus, Type 2 by Vanderbilt University Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06852950Vanderbilt University Medical CenterContinuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge | 2027-01 |
| NCT07210593Vanderbilt University Medical CenterSTrong Relationships to Improve DiabEtes Pilot | 2027-03 |
Among the 21 studies in Diabetes Mellitus, Type 2 by Vanderbilt University Medical Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive active calcium-HMB plus vitamin D3 for approximately 6 months while semaglutide is prescribed and managed as standard clinical care.
Dietary Supplement: Calcium-HMB Plus Vitamin D3
Participants receive matching placebo for approximately 6 months while semaglutide is prescribed and managed as standard clinical care.
Other: Matching placebo
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.
Also known as: CaHMB plus vitamin D3, beta-hydroxy-beta-methylbutyrate plus vitamin D3, HMB plus vitamin D3
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.
This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.
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.
Time frame: Baseline to month 6
Title Change in Body Weight
Body weight measured using a calibrated scale; change calculated as month 6 minus baseline, in kilograms.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to month 6
Change in Trabecular Bone Score
Trabecular bone score derived from DXA; change calculated as month 6 minus baseline.
Time frame: Baseline to month 6
Change in Glycated Hemoglobin
HbA1c measured from blood samples; change calculated as month 6 minus baseline, in percent.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, month 3, and month 6
Change in Six-Minute Walk Distance
Distance walked during the six-minute walk test, in meters.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From first study-product dose through completion of month-6 follow-up or resolution/stabilization of ongoing events
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The funded plan describes sharing deidentified datasets within 6 months after publication or within 18 months after the funding period ends if unpublished. Confirm that this remains the final institutional commitment before entering it.
Access criteria: Access will require repository review and any required data-use agreement, institutional approval, and agreement to use the data only for an approved research purpose and not to attempt participant reidentification.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Nov 2029, 35 months later.
Of 99 non-industry phase 2 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 35 months is close to that.
Counting every sponsor, half of 293 studies reached it within 15 months; a quarter within 11 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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