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NCT03292315 · ClinicalTrials.gov registry record · Phase 4
Once Weekly GLP-1 in Persons With Spinal Cord Injury
A Phase 4 study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT03292315 is a Phase 4 study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 5 participants.
The verdict
NCT03292315, a Phase 4 study, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER No Intervention
- DRUG Semaglutide 1MG Injection [Ozempic]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2023-03-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03292315
The ClinicalTrials.gov registry entry for NCT03292315 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which No Intervention is the first listed.
NCT03292315 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03292315 about?
NCT03292315 is a clinical study titled "Once Weekly GLP-1 in Persons With Spinal Cord Injury". 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 pre...
What is the current status of trial NCT03292315?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2018-10-16. Estimated completion is 2023-03-01.
What interventions are being tested in trial NCT03292315?
The interventions under investigation include: No Intervention (OTHER), Semaglutide 1MG Injection [Ozempic] (DRUG).
Who is sponsoring clinical trial NCT03292315?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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