Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of GLP-1 Receptor Agonists on Trabecular Bone Score and Visceral Adiposity in Postmenopausal Women With Type 2 Diabetes Mellitus.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04964388
• Other study ID #: UMississippi
• Status: Recruiting
• Phase: Phase 2
• Start date: November 9, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: University of Mississippi Medical Center
• Contact: Vishnu V Garla
• Phone: 3049726961
• Email: vgarla[@]umc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• GLP-1 receptor agonist
Diabetes medication

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trabecular bone score	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.	12 months after index date
Secondary	Inflammatory markers and Bone resorption markers	The change in inflammatory markers (IL-1, IL-6 and TNF-alpha) and bone resorption markers (C-telopeptide) at 6 and 12 months after starting GLP-1 receptor agonists as compared to baseline.	12 months after index date
Secondary	Visceral fat mass	The change in visceral fat mass (measured by DXA) at 6 and 1 year after starting GLP-1 receptor agonists as compared to baseline.	12 months after index date
Secondary	Sclerostin and Bone formation markers	The change in levels of sclerostin, osteocalcin, and P1NP (as measured by commercial assays) from baseline to six months and one year after starting GLP-1 receptor agonist.	12 months after index date