[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07428746":3,"trial-entities:NCT07428746":145,"trial-summary:NCT07428746":149},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":46,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":14,"eligibility_criteria":83,"std_ages":115,"locations":117,"central_contacts":136,"overall_officials":141,"references":143,"see_also_links":144},"NCT07428746","2025P013673","Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes","RECRUITING","2028-11","2026-07","2026-08-03","2026-05-07","Emory University","OTHER",false,"The goal of this study is to learn how GLP-1 receptor agonist therapy affects muscle and bone health in older females over age 65 with type 2 diabetes.\n\nThe main question it aims to answer is whether or not 6 months of GLP-1 RA therapy affects muscle strength.\n\nParticipants will:\n\n* Receive GLP-1 RA therapy as part of their routine clinical care\n* Complete muscle strength assessments (hand grip strength, Timed Up and Go test)\n* Provide blood samples for bone turnover markers\n* Undergo bone mineral density testing","Older females with type 2 diabetes experience a disproportionately high burden of osteosarcopenia, a condition defined by the coexistence of low muscle mass, reduced muscle strength, and decreased bone mineral density. Osteosarcopenia is associated with increased risks of falls, fractures, functional decline, hospitalization, and loss of independence. Diabetes contributes to these risks through multiple mechanisms, including impaired bone microarchitecture, reduced muscle quality, neuropathy-related balance disturbances, and chronic inflammation. These effects are amplified in older women, who already experience age-related declines in muscle and bone health following menopause.\n\nGlucagon-like peptide-1 receptor agonists (GLP-1 RAs), including semaglutide, are widely used for glycemic management and weight reduction in type 2 diabetes. While these medications provide substantial metabolic benefits, clinical studies have reported that weight loss associated with GLP-1 RA therapy may include reductions in lean body mass. The implications of these changes for muscle strength, bone turnover, and bone mineral density remain unclear, particularly in older females with type 2 diabetes who may be more vulnerable to muscle and bone loss. Existing data on GLP-1 RAs and fracture risk are limited and inconsistent, and most prior studies have evaluated older, less potent agents with minimal weight-loss effects.\n\nThis prospective observational study is designed to characterize changes in muscle and bone health during 6 months of GLP-1 RA therapy in older females with type 2 diabetes who are receiving treatment as part of routine clinical care. The study will enroll 20 women over the age of 65. Participants will undergo standardized assessments of muscle strength, bone turnover markers, and bone mineral density at baseline and follow-up. Muscle strength will be evaluated using validated functional measures, and bone health will be assessed through laboratory markers of bone remodeling and imaging-based measures of bone density.\n\nThe study does not alter clinical treatment decisions; GLP-1 RA therapy is prescribed independently by participants' healthcare providers based on FDA-approved indications. Study procedures focus on evaluating physiological changes associated with treatment in a population at elevated risk for osteosarcopenia. Data collected will help clarify whether GLP-1 RA therapy influences muscle strength, bone turnover, or bone mineral density in older females with type 2 diabetes. Findings may inform future strategies to support musculoskeletal health in this growing and medically vulnerable population.",[18],"Diabetes Mellitus, Type 2",[20,21,22,23,24,25],"GLP-1 Receptor analogs","Semaglutide","DEXA","Osteosarcopenia","Bone Mineral Density","Bone turnover markers","INTERVENTIONAL","TREATMENT",[29],"PHASE3",{"count":31,"type":32},20,"ESTIMATED",[34],{"type":35,"name":21,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Semaglutide is an FDA-approved drug for the treatment of T2D at the following doses (0.25, 0.5, 1, and 2 mg) that is self-administered weekly using an autoinjector pen.\n\nThe drug dosage will gradually increase every 4 weeks if tolerated to reach maintenance doses of 2 mg for semaglutide until the end of the study (6 months). If a participant cannot tolerate a dose, the highest tolerable dose will be administered, with continued efforts to increase the dose over time, gradually.",[38],"Type 2 Diabetics on Semaglutide",[40],"GLP 1 RA",[42],{"measure":43,"description":44,"timeFrame":45},"Change in handgrip strength","Handgrip strength is a validated indicator of overall muscle strength and a core diagnostic component of sarcopenia. HGS will be assessed using a calibrated hydraulic hand dynamometer.\n\nOutput is recorded in kilograms (kg) of force. Higher values indicate greater muscle strength","Baseline, week4, week 8, week12, week 26.",[47,51,54,57,61,64,67,71,74,77],{"measure":48,"description":49,"timeFrame":50},"Change in bone turnover markers","Bone turnover markers (BTMs) reflect the rate of bone remodeling, including both bone formation and bone resorption processes. These laboratory biomarkers provide insight into dynamic skeletal changes that may occur during GLP-1 receptor agonist therapy.\n\nBTMs may include:\n\n* Bone formation markers (e.g., P1NP)\n* Bone resorption markers (e.g., CTX) Results will be reported in standard laboratory units (e.g., ng\u002FmL, µg\u002FL), depending on the specific assay.\n\nHigher formation markers indicate increased bone formation; higher resorption markers indicate increased bone breakdown","Baseline, 3 month, 6 months",{"measure":52,"description":53,"timeFrame":45},"Change in timed up-and-go (TUG)","The Timed Up and Go (TUG) test assesses functional mobility by measuring the time required for a participant to rise from a standard chair, walk to a marked 10-foot line, turn around, return to the chair, and sit down.\n\nTime is recorded in seconds (s).\n\n* Shorter times indicate better functional mobility.\n* Longer times may reflect impairments in balance, gait speed, or lower-extremity strength.",{"measure":55,"description":56,"timeFrame":50},"Change in HbA1c","Collected via venous blood sample and analyzed using standardized laboratory assays.\n\nHbA1c will be reported as a percentage (%). Reductions in HbA1c and fasting glucose reflect improved insulin sensitivity and glycemic regulation.",{"measure":58,"description":59,"timeFrame":60},"Change in fasting glucose","Measured after an overnight fast of at least 8 hours. Fasting glucose will be reported in mg\u002FdL. Reductions in fasting glucose reflect improved insulin sensitivity and glycemic regulation","Baseline, 6 months",{"measure":62,"description":63,"timeFrame":45},"Change in weight","Measured using a calibrated digital scale with participants wearing light clothing and no shoes.\n\nBody weight will be reported in kilograms (kg).\n\nWeight change (kg) will be calculated as the difference between baseline and follow-up measurements",{"measure":65,"description":66,"timeFrame":60},"Change in FRAX score","Fracture risk will be evaluated using the FRAX algorithm, which integrates bone mineral density (BMD) at the femoral neck with validated clinical risk factors to estimate the 10-year probability of major osteoporotic fracture and hip fracture.\n\nFRAX results are expressed as percent probabilities (%). Lower percentages indicate reduced fracture risk.",{"measure":68,"description":69,"timeFrame":70},"Change in lipid profile","Serial lipid measurements will be collected to evaluate cardiovascular risk modification during GLP-1 receptor agonist therapy.\n\nLDL-C, HDL-C, triglycerides, and total cholesterol will be reported in mg\u002FdL.\n\n* Change in each lipid parameter will be calculated as the difference between baseline and 6-month values.\n* Lower LDL-C and triglycerides, along with higher HDL-C, indicate improved cardiovascular risk profiles.","Baseline, 3 months, 6 months",{"measure":72,"description":73,"timeFrame":60},"Changes in exercise frequency","The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire is a validated self-report tool designed to assess weekly frequency and duration of lifestyle physical activities commonly performed by older adults. It captures a broad range of activities across light, moderate, and vigorous intensities, providing a comprehensive estimate of habitual physical activity.\n\nResponses are used to calculate the total weekly frequency of various activity categories.\n\nWeekly frequency of each activity (number of sessions per week)",{"measure":75,"description":76,"timeFrame":60},"Changes in exercise duration","The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire is a validated self-report tool designed to assess weekly frequency and duration of lifestyle physical activities commonly performed by older adults. It captures a broad range of activities across light, moderate, and vigorous intensities, providing a comprehensive estimate of habitual physical activity.\n\nResponses are used to calculate the total weekly duration of various activity categories.\n\nHigher values indicate greater physical activity engagement.",{"measure":78,"description":79,"timeFrame":60},"Change in frailty assessment","Frailty will be assessed using a questionnaire based on the Fried phenotype, evaluating five components: unintentional weight loss, exhaustion, low physical activity, slowness, and weakness. A structured data capture form modeled on the validated assessment will be used.\n\nAssessment Procedure \\& Scoring:\n\n* Completed at baseline and 6 months.\n* Each criterion is scored as present or absent (0-5 total).\n* 0: Non-frail\n* 1-2: Pre-frail\n* ≥3: Frail\n\nInterpretation:\n\nHigher scores indicate greater frailty; changes over time reflect shifts in physiologic vulnerability.","FEMALE","65 Years",null,{"inclusion":84,"exclusion":92,"raw_text":114},[85,86,87,88,89,90,91],"Postmenopausal women aged 65 years or older","Has type 2 diabetes","Body Mass Index (BMI) ≥27 kg\u002Fm² to max 40kg\u002Fm2 (inclusive)","Hemoglobin A1c \\>7% within 3 months of the first visit.","Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.","No osteoporosis confirmed on DEXA scan within 12 months","Able to provide informed consent and participate in all study assessments",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113],"Patients with type 1 diabetes mellitus or other types of diabetes that are not T2D","eGFR \\\u003C30 ml\u002Fmin in the last 3 months","Patients with a history of treatment with anti-osteoporosis agents","Documented primary or secondary osteoporosis on a DEXA scan within the last 12 months, or are on osteoporosis therapies","Documented presence of prosthesis or devices in the spine or hip","Previous fragility fracture","Males","Moderate to severe gastroesophageal reflux disease based on patient history.","Inability to comply with the treatment protocol or to understand the consent form.","Aspartate aminotransferase (AST) \\> 3 times normal or alanine aminotransferase (ALT) \\> 3 times the normal","Subjects with uncontrolled thyroid or parathyroid disease that may influence the study results.","Personal or family history of medullary thyroid carcinoma.","Personal or family history of multiple endocrine neoplasia type 2 syndrome.","Personal history of gastroparesis, celiac disease, hypogonadism, severe COPD, hypopituitarism, or Cushing's disease","Personal history of severe diabetic retinopathy.","Known serious hypersensitivity, including anaphylaxis and angioedema, to semaglutide or any of its excipients.","Any of the following drugs or treatments were used within 6 months before screening: treated with GLP-1RA, GIP analogues, pioglitazones","Concomitant treatment with GLP-1 receptor agonist therapy","Long-term intravenous, oral, and intra-articular administration of high-dose corticosteroids within 2 months before screening (more than 7 days in a row)","Use of weight control drugs or surgery that can lead to weight changes during the last 6 months before screening, or are currently in the weight loss plan and are not in the maintenance stage","Incarcerated individuals","Inclusion Criteria:\n\n* Postmenopausal women aged 65 years or older\n* Has type 2 diabetes\n* Body Mass Index (BMI) ≥27 kg\u002Fm² to max 40kg\u002Fm2 (inclusive)\n* Hemoglobin A1c \\>7% within 3 months of the first visit.\n* Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.\n* No osteoporosis confirmed on DEXA scan within 12 months\n* Able to provide informed consent and participate in all study assessments\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes mellitus or other types of diabetes that are not T2D\n* eGFR \\\u003C30 ml\u002Fmin in the last 3 months\n* Patients with a history of treatment with anti-osteoporosis agents\n* Documented primary or secondary osteoporosis on a DEXA scan within the last 12 months, or are on osteoporosis therapies\n* Documented presence of prosthesis or devices in the spine or hip\n* Previous fragility fracture\n* Males\n* Moderate to severe gastroesophageal reflux disease based on patient history.\n* Inability to comply with the treatment protocol or to understand the consent form.\n* Aspartate aminotransferase (AST) \\> 3 times normal or alanine aminotransferase (ALT) \\> 3 times the normal\n* Subjects with uncontrolled thyroid or parathyroid disease that may influence the study results.\n* Personal or family history of medullary thyroid carcinoma.\n* Personal or family history of multiple endocrine neoplasia type 2 syndrome.\n* Personal history of gastroparesis, celiac disease, hypogonadism, severe COPD, hypopituitarism, or Cushing's disease\n* Personal history of severe diabetic retinopathy.\n* Known serious hypersensitivity, including anaphylaxis and angioedema, to semaglutide or any of its excipients.\n* Any of the following drugs or treatments were used within 6 months before screening: treated with GLP-1RA, GIP analogues, pioglitazones\n* Concomitant treatment with GLP-1 receptor agonist therapy\n* Long-term intravenous, oral, and intra-articular administration of high-dose corticosteroids within 2 months before screening (more than 7 days in a row)\n* Use of weight control drugs or surgery that can lead to weight changes during the last 6 months before screening, or are currently in the weight loss plan and are not in the maintenance stage\n* Incarcerated individuals",[116],"OLDER_ADULT",[118],{"facility":119,"status":7,"city":120,"state":121,"zip":122,"country":123,"contacts":124,"geoPoint":133},"Grady Memorial Hospital","Atlanta","Georgia","30303","United States",[125,130],{"name":126,"role":127,"phone":128,"email":129},"Thaer Idrees, MD, FSSCI","CONTACT","404-251-5357","thaer.idrees@emory.edu",{"name":131,"role":132},"Thayer Idrees, MD","PRINCIPAL_INVESTIGATOR",{"lat":134,"lon":135},33.749,-84.38798,[137,138],{"name":126,"role":127,"phone":128,"email":129},{"name":139,"role":127,"email":140},"Jaafer Zaino","jaafer.zaino@emory.edu",[142],{"name":126,"affiliation":12,"role":132},[],[],{"nct_id":4,"conditions":146,"biomarkers":148},[147],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":150,"summary":151,"prompt_version":161},true,{"design":152,"status":153,"heading":154,"summary":155,"follow_up":156,"word_count":157,"commitments":158,"compensation":159,"drugs_mentioned":160},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.","completed","Investigating Semaglutide for Muscle and Bone Health in Older Women with Type 2 Diabetes","This study is looking at how a common diabetes medication, Semaglutide (a GLP-1 RA therapy), affects muscle and bone health in women aged 65 or older who have type 2 diabetes. Researchers want to see if 6 months of Semaglutide treatment changes muscle strength, specifically handgrip strength. You might be able to join if you are a postmenopausal woman over 65 with type 2 diabetes, a BMI between 27 and 40, and an A1c between 7-10%. The study is currently unclear on its recruitment status and plans to enroll 20 participants.","Muscle strength will be measured at Baseline, week 4, week 8, week 12, and week 26.",91,"You would receive Semaglutide, have muscle strength tests (hand grip, Timed Up and Go), provide blood samples, and undergo bone mineral density testing. The main muscle strength assessment will be measured at Baseline, week 4, week 8, week 12, and week 26.","Not stated in the trial record.",[21],"v2"]