Once Weekly GLP-1 in Persons With Spinal Cord Injury

Conditions

• Insulin Resistance
• Obesity
• Pre Diabetes
• Spinal Cord Injuries

Eligibility Criteria

Sex

ALL

Age

18 Years - 69 Years

Healthy Volunteers

Not accepted

Interventions

• Semaglutide 1MG Injection [Ozempic] — DRUG
  Once weekly injection of 1mg of Semaglutide.
• No Intervention — OTHER
  No injection will be administered

Study Details

Chronic spinal cord injury (SCI) results in adverse soft tissue body composition changes and an extremely sedentary lifestyle. These abrupt changes often lead to a high prevalence of cardiometabolic diseases, such as impaired glucose tolerance/diabetes mellitus and dyslipidemia, conditions which predispose those with SCI to an increased risk for cardiovascular disease compared to the general population. Due to paralysis and wheel chair dependence, maintaining an adequate level of physical activity to counteract these deleterious metabolic changes presents a unique obstacle because conventional first line interventions are lifestyle modifications (e.g., diet and exercise), which may be difficult to achieve. Recently, a new medication has been approved by the Food and Drug Administration to improve glycemic control in individuals with diabetes mellitus, and it has also been investigated as an off-label treatment to induce weight loss. Glucagon-like peptide-1 (GLP-1) agonists are a class of drugs designed to mimic the endogenous incretin hormones released from the gut in a glucose dependent manner following a meal. The mechanisms of action for this drug class of medications include stimulation of glucose-dependent insulin secretion, inhibiting glucagon release, slowed gastric emptying, and reduction of postprandial glucose excursions following food intake. In addition to improved glycemic control, this class of medications also shows promise for its non-glycemic action of facilitating weight loss. The method of delivery of the GLP-1's is by self-administered injections once daily or once weekly, depending on the severity of the clinical case and therapeutic targets for a specific patient.

Key Dates

Start date

Oct 16, 2018

Status verified

Mar 2023

Primary completion

Mar 1, 2020

Completion

Mar 1, 2023

Study Design

Enrollment

5 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide 1MG Injection [Ozempic]
  20 subjects will be randomized to receive once weekly injection of Semaglutide (Ozempic1mg) for 26 weeks.
• Other: No Intervention
  10 subjects will be randomized to receive no intervention for 26 weeks.

Primary Outcome Measure

Body Weight [ Time Frame: Baseline, Week 13, Week 26 ]

Locations (1)

Find similar trials in West Orange, NJ

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