[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651334":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":43,"responsibleParty":56,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":33,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":101,"whyStopped":33,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Dietary Supplement: Calcium-HMB Plus Vitamin D3",{"label":15,"type":16,"description":17,"interventionNames":18},"Matching Placebo","PLACEBO_COMPARATOR","Participants receive matching placebo for approximately 6 months while semaglutide is prescribed and managed as standard clinical care.",[19],"Other: Matching placebo",[21,29],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","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.",[9],[26,27,28],"CaHMB plus vitamin D3","beta-hydroxy-beta-methylbutyrate plus vitamin D3","HMB plus vitamin D3",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Matching placebo","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.",[15],null,[35],{"name":36,"affiliation":5,"role":37},"Robb Flynn, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":33,"email":42},"CONTACT","615-342-8329","robb.flynn@vumc.org",[44],{"facility":5,"status":33,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":33},"Nashville","Tennessee","37232","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-86.78444,36.16589,{"lat":54,"lon":53},{"type":37,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Charles R. Flynn","Associate Professor",[60],{"name":61,"class":6},"American Diabetes Association","100651334","phase-2-hmb-plus-vitamin-d-to-preserve-muscle-in-older-adults-starting-semaglutide-100651334",false,"NCT07760948","HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide","Preserving the Metabolic Engine: HMB Supplementation to Combat Iatrogenic Sarcopenia and Metabolic Adaptation in Older Adults Initiating Semaglutide Therapy","PRESERVE-HMB","Inclusion Criteria:\n\n* Age 65 to 85 years, inclusive.\n* Type 2 diabetes mellitus, defined by HbA1c at or above 6.5% or current use of antihyperglycemic medication.\n* Body mass index at or above 27 kg\u002Fm2.\n* Newly initiating semaglutide as standard clinical care under the direction of a treating clinician.\n* Able to walk 400 meters without assistance; use of a cane is permitted.\n* Able to understand and provide legally effective informed consent.\n* 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.\n\nExclusion Criteria:\n\n* Estimated glomerular filtration rate below 45 mL\u002Fmin\u002F1.73 m2.\n* Use of HMB, creatine, or high-dose whey protein supplements within the previous 3 months.\n* Weight change greater than 5% during the previous 3 months.\n* Recent fracture within the previous 6 months.\n* Neuromuscular disease, including Parkinson disease, or another condition that would interfere with study outcomes or safe participation.\n* Chronic corticosteroid use.\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.\n* History of pancreatitis.\n* Smoking more than 7 cigarettes per day.\n* Previous malabsorptive or restrictive intestinal surgery or a malabsorptive syndrome.\n* Pregnancy or breastfeeding.\n* Recent history of neoplasia within the previous 5 years, as defined by the protocol.\n* Other active inflammatory conditions or neuromuscular disorders that could interfere with study outcomes or safety.\n* Serum 25-hydroxyvitamin D below 15 ng\u002FmL.\n* Any medical, functional, laboratory, medication-related, or safety condition that the investigator determines makes study participation unsafe or prevents completion of essential procedures.","ALL","65 Years","85 Years",{"count":74,"type":75},90,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","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.",[81,82,83,84,85],"Type 2 Diabetes Mellitus (T2DM)","Sarcopenia","Obesity","Muscle Loss","Older Adults",[87,88,89,90,91,92,93,94,95,96,97,98,99,100],"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","NOT_YET_RECRUITING","2026-08-07",{"date":104,"type":105},"2026-08-12","ACTUAL",{"date":107,"type":75},"2026-12-01",{"date":109,"type":75},"2030-11",{"name":5,"class":6},1]