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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Marzieh Salehi
Study ID
NCT06706284
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Injectable Product — DRUG
    A GLP-1 inhibitor used to control T2DM
  • Placebo — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 11, 2025
Status verified
Apr 2026
Primary completion
Sep 1, 2028
Completion
Mar 1, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCI and T2DM Treatment Group
    Participants with spinal cord injury (SCI) and type 2 diabetes (T2DM) will be assigned to semaglutide weekly for 24 weeks. Semaglutide administration: once-weekly self-administration of SGT, titrated to a dose of 2 mg/week as per FDA approved guidelines. All subjects will be instructed how to inject and titrate up the dose.
  • Placebo Comparator: SCI and T2DM Placebo Group
    Participants with spinal cord injury (SCI) and type 2 diabetes (T2DM) will be assigned to the placebo group and inject normal saline weekly for 24 weeks. All subjects in the placebo group will be instructed how to inject and titrate up the dose to mimic the semaglutide administration to a maximum dose of 2 mg in 12 weeks and then continue for remainder of study.

Primary Outcome Measure

Glucose tolerance [ Time Frame: Baseline to 24 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University Health - Texas Diabetic InstituteSan AntonioTexas78207
Matthew A Davis
[email protected]
Mooney Mark-Johnson
[email protected]
Marzieh Salehi, MD, MS (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Matthew A Davis
[email protected]
Mooney Mark-Johnson
[email protected]
Marzieh Salehi, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Antonio, TX

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University Health - Texas Diabetic Institute· San Antonio, TXUniversity of Texas Health Science Center at San Antonio· San Antonio, TX

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