Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

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

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)

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Osteoporosis, Postmenopausal
• Intervention / Treatment: Drug: GLP-1 receptor agonist

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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Vishnu V Garla; Phone Number: 3049726961; Email: vgarla@umc.edu

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • University of Mississippi Medical Center
      • Contact: Vishnu V Garla; Phone Number: 304-972-6961; Email: vgarla@umc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLP-1 cohort; Participants on GLP-1 receptor agonists	Drug: GLP-1 receptor agonist; Diabetes medication
No Intervention: Non GLP-1 cohort; Participants not on GLP-1 receptor agonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Investigators: Principal Investigator: Vishnu V Garla, MD, University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Diabetes Mellitus; Diabetes Mellitus, Type 2; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: UMississippi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No