Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
Marzieh Salehi
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.
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…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and female subjects aged 18-70 years (inclusive) at screening 2. More than one year after spinal cord injury 3. Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D. 4. Provision of signed and dated written informed consent prior to any study specific procedures 5. Diagnosed with T2DM with glucose control managed with diet and metformin monotherapy where no significant dose changes (increase or decrease ≥ 50%) have occurred in the three months prior to screening 6. HbA1c 6.0-9.0% at screening 7. BMI \> 22 kg/m2 at screening 8. Female subjects of childbear…
Interventions
- DrugSemaglutide Injectable Product
A GLP-1 inhibitor used to control T2DM
- OtherPlacebo
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.
Locations (2)
- University Health - Texas Diabetic InstituteSan Antonio, Texas
- University of Texas Health Science Center at San AntonioSan Antonio, Texas