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RecruitingPhase 3

Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will: * Receive GLP-1 RA therapy as part of their routine clinical care * Complete muscle strength assessments (hand grip strength, Timed Up and Go test) * Provide blood samples for bone turnover markers * Undergo bone mineral density testing"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how GLP-1 receptor agonist (GLP-1 RA) medicines affect muscle and bone health in women age 65 or older with type 2 diabetes. It mainly tests whether muscle strength changes after 6 months of treatment given as part of regular care. Participants will have strength tests, blood tests, and bone density scans.

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. The main question it aims to answer is whether or not 6 months of GLP-1 RA therapy affects muscle strength. Participants will: * Receive GLP-1 RA therapy as part of their routine clinical care * Complete muscle strength assessments (hand grip strength, Timed Up and Go test) * Provide blood samples for bone turnover markers * Undergo bone mineral density testing

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 65 or older who have gone through menopause.
  • Have type 2 diabetes.
  • Have a body mass index (BMI), a measure based on height and weight, from 27 to 40.
  • Have an A1c above 7% within 3 months before the first visit. A1c measures average blood sugar.
  • Can follow all study steps, including going without food when required for some visits.
  • Have a DEXA bone density scan from the past 12 months showing no osteoporosis, a disease that weakens bones.
  • Can give informed consent and take part in all study tests.

Who can't join

  • Are male, have a type of diabetes other than type 2, are in prison or jail, or cannot follow study steps or understand the consent form.
  • Have osteoporosis on a bone scan from the past 12 months, take or have taken medicines for osteoporosis, have an implant or device in the spine or hip, or have had a bone break from a minor injury.
  • Have a kidney filtering rate (eGFR) below 30 in the past 3 months, liver blood tests called AST or ALT above 3 times normal, or severe diabetes-related eye damage.
  • Have moderate to severe acid reflux; slow stomach emptying; celiac disease, which causes gut damage from gluten; or severe COPD, a lung disease.
  • Have uncontrolled thyroid or parathyroid disease that could affect the results; low sex hormone levels; low pituitary hormone levels; or Cushing's disease, which causes too much of the hormone cortisol. A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that causes gland tumors, also rules you out.
  • Have a known serious allergy to semaglutide or any of its ingredients.
  • Used GLP-1 RA medicines, GIP analogues, or pioglitazones within 6 months before screening, or are taking GLP-1 RA treatment at the same time. Long-term, high-dose steroids given by vein, mouth, or joint injection for more than 7 days in a row within 2 months before screening also rule you out.
  • Used weight-control medicines or had surgery that can change weight within 6 months before screening, or are in a weight-loss plan and have not yet reached the stage of keeping weight steady.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Postmenopausal women aged 65 years or older * Has type 2 diabetes * Body Mass Index (BMI) ≥27 kg/m² to max 40kg/m2 (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 Exclusion Criteria: * Patients with type 1 diabetes mellitus or other types of diabetes that are not T2D * eGFR \<30 ml/min 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

Study sites (1)

GA