Effect of GLP-1 Receptor Agonists on Trabecular Bone Score and Visceral Adiposity in Postmenopausal Women With Type 2 Diabetes Mellitus.
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Trabecular Bone Score
Study Overview
Brief Summary
This study will help determine the effect of Glucagon Like Peptide-1 (GLP-1)receptor agonists on bone strength in postmenopausal women with type 2 diabetes mellitus (T2DM)
Detailed Description
Postmenopausal women with diabetes mellitus have a higher risk of osteoporotic fractures, with significant associated mortality and morbidity. Osteoporosis is underdiagnosed in diabetes, as the bone mineral density (BMD) as currently measured is often normal despite underlying abnormalities. The trabecular bone score (TBS) is a novel modality to assess bone microarchitecture and accurately assess fracture risk in patients with diabetes. Due to increased co-prevalence of osteoporosis and diabetes mellitus, the potential effects of antidiabetic medications on fracture risk assume importance.
Based on findings in animal studies, we hypothesize that GLP-1 receptor agonists increase TBS in postmenopausal women with (T2DM). The investigators propose a prospective non-randomized study by enrolling 48 patients (24 in the GLP-1 group and 24 in the non-GLP group). Dual-energy X-ray Absorptiometry (DXA )scans, markers of bone formation, and resorption, and selected inflammatory markers will be assessed at baseline, six months, and one year.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Type 2 Diabetes Mellitus
- •Postmenopausal female
- •Age >55 years
- •Hemoglobin A1c between 7-10% within 6 months of the first visit.
Exclusion Criteria
- •Patients with type 1 Diabetes mellitus
- •Patients with a history of GLP-1 receptor agonist/DPP4 inhibitor use
- •eGFR <30 ml/min in the last 3 months
- •Patients with a history of pancreatitis
- •Personal or family history of medullary thyroid cancer
- •Patients with a history of treatment with anti-osteoporosis agents
- •Documented secondary osteoporosis
- •Documented presence of prosthesis or devices in the spine
- •Unwilling or unable to consent
Arms & Interventions
GLP-1 cohort
Participants on GLP-1 receptor agonists
Intervention: GLP-1 receptor agonist (Drug)
Outcomes
Primary Outcomes
Trabecular Bone Score
Time Frame: 12 months after index date
The change in TBS from baseline to six months and one year after the initiation of a GLP-1 receptor agonist. TBS will be assessed by DXA scans done at baseline, six months and one year.
Secondary Outcomes
- Sclerostin and Bone Formation Markers(12 months after index date)
- Visceral Fat Mass(12 months after index date)
- Inflammatory Markers and Bone Resorption Markers(12 months after index date)