NCT06706284

Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Marzieh Salehi · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

It is not known whether a new diabetes drug, semaglutide, is an effective treatment for type 2 diabetes for persons with spinal cord injury (SCI), a population at higher risk for this condition. Therefore, this study looks at the effect of semaglutide on glucose levels in the body and other information about type 2 diabetes and obesity.

Detailed description

This study consists of 7-9 in-person visits and 9-10 phone visits, and participants will be randomized to either semaglutide or placebo for 24 weeks. The participants first visit, will include review of medical history and performance of standard tests to check the participant's health and eligibility for the study. Before starting any medication, participants will have 2 more visits: * a mixed meal tolerance test, to examine their body's response to nutrient ingestion and * a glucose clamp study to examine insulin sensitivity. These tests will be scheduled on two separate days. Following the 3 baseline visits, participants will be randomized to either the intervention (once-weekly injection of semaglutide, also known as Ozempic, for 24 weeks) or placebo. During the 24-week intervention participants will receive 9-10 phone calls to discuss their progress and experiences with the interventions and will also be asked to return for a short research visit including interim medical history with or without blood sample collection twice. At the end of 24 weeks, the treatments will be discontinued, and participants will repeat the meal and glucose studies scheduled over two separate days. During participation, fat/lean mass will be measured using DEXA and liver fat mass may be measured using fibroscan. In addition, participants may be asked for a stool sample.

Conditions

• Spinal Cord Injuries
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Semaglutide Injectable Product	A GLP-1 inhibitor used to control T2DM
OTHER	Placebo	Saline solution will be administered with the same frequency as semaglutide and participants will be instructed how to use the saline in the same manner as the active drug group.

Timeline

• Start date: 2025-04-11
• Primary completion: 2028-09-01
• Completion: 2029-03-01
• First posted: 2024-11-26
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study