Purpose

This study well measure the effectiveness of semaglutide on insulin sensitivity, body weight and fat/lean mass in subjects spinal cord injuries and diabetes

Category

IRB Number
STUDY00000591
NCT Number
NCT06706284
Sponsor
Marzieh Salehi -



Study Contact

Mooney Mark-Johnson
210 450 8696
markjohnson@uthscsa.edu

Jessica Pena
penaj21@uthscsa.edu

Noelle Vinson
832-856-1520
vinsonn@uthscsa.edu

Principal Investigator
Marzieh Salehi

Andrea Hansis-Diarte
210-567-3208
hansisdiarte@uthscsa.edu

Mooney Mark-Johnson
210 450 8696
markjohnson@uthscsa.edu



Eligibility

Eligible Ages
18-70
Eligible Genders
all
Accepts Healthy Volunteers
No

Inclusion Criteria

    spinal cord injury (greater than 1 year post SCI)

    type 2 diabetes (BMI >22kg/m2)

Exclusion Criteria

    older than 70

    pregnant


Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Controlled 2 arm assignment study. The investigators will stochastically match the patient characteristics between the two arms using for a 2:1 design in terms of level of gender (male, female), level of injury (tetraplegia, paraplegia), dichotomized baseline HbA1c (above or below 7.5%), dichotomized age (above or below a median age for this population) and dichotomized BMI (above or below a median BMI for this population)
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
Patients will be blinded to the treatment assignment. The study team will be unblinded. The investigators will deliver the treatment assignments to the hospital pharmacist as they occur.
Condition
  • Spinal Cord Injuries
  • Type 2 Diabetes

    • Arm Groups

    ArmDescriptionIntervention
    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.
  • 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.

    Other names:

    • Saline solution

    • 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.
  • Drug: Semaglutide Injectable Product

    A GLP-1 inhibitor used to control T2DM

    Other names:

    • Ozempic

    •