Trial · Interventional

CompletedPhase 4Registry data

Once Weekly GLP-1 in Persons With Spinal Cord Injury

NCTNCT03292315Other idBAU-17-038

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 5 participants (actual)
Sponsor: James J. Peters Veterans Affairs Medical Center · Fed
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 16 Oct 2018
Primary completion: 1 Mar 2020
Completion: 1 Mar 2023
First posted: 25 Sept 2017
Last update posted: 14 Mar 2023
Conditions: Spinal Cord Injuries · Insulin Resistance · Pre Diabetes · Obesity

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2018201920202021202220232024

Ph 4
Once Weekly GLP-1 in Persons With Spinal Cord Injury
NCT03292315
16 Oct 2018 to 1 Mar 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Semaglutide 1MG Injection [Ozempic]Drug
No InterventionOther

Arms2

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 outcomes3

Outcomes the sponsor listed as primary.

Body Weight
Time frame · Baseline, Week 13, Week 26
Registry description
Efficacy of GLP-1 to reduce total body weight determined by Dual Energy Absorptiometry (DXA)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame · Baseline, Week 13, Week 26
Registry description
Efficacy of GLP-1 to reduce HOMA-IR
Homeostatic Model Assessment of Beta-Cell Function (HOMA-B)
Time frame · Baseline, Week 13, Week 26
Registry description
Efficacy of GLP-1 to increase HOMA-B

Secondary outcomes(2)

Body Fat
Time frame · Baseline, Week 13, Week 26
Registry description
Efficacy of GLP-1 to reduce total body fat determined by Dual Energy Absorptiometry (DXA)
Glycated Hemoglobin (HbA1C)
Time frame · Baseline, Week 13, Week 26
Registry description
Efficacy of GLP-1 to reduce HbA1C

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

6 results

Preliminary observations on the administration of a glucagon-like peptide-1 receptor agonist on body weight and select carbohydrate endpoints in persons with spinal cord injury: A controlled case series.

Cirnigliaro et al. 2024The journal of spinal cord medicinecited by 9

PMID 37158751PMC11218576DOI 10.1080/10790268.2023.2207064PUB-37158751

Rights unknown6 results

Source link See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 69 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Male or female, age 18 to 69; 2. Chronic (e.g., duration of injury greater than 3 years) stable SCI (regardless of level of neurological injury); 3. ASIA A-D (non-ambulatory defined as not able to weight bear for more than 20% of the day); 4. Obese Percent Body Fat defined as \> 25% for men and \> 35% for women (as determined by screening DXA scan); 5. Insulin Resistant as determined at screening: (FPI, ≥15 µU/ml); -OR- 6. Pre-diabetic, as determined by any one of the following: 1. HbA1C ≥ 5.7% and \< 6.4%; or 2. Impaired glucose tolerance by FSG ≥100 mg/dl and \< 125 mg/dl and/or the 2 hour serum glucose concentration (after an OGTT) ≥ 140 mg/dl and \< 200 mg/dl Exclusion Criteria: 1. Personal history of or family history of medullary thyroid carcinoma; 2. History of multiple endocrine neoplasia syndrome type 2; 3. History of pancreatitis; 4. Existing diagnosis of diabetes mellitus, or the results from screening OGTT that identify diabetes mellitus (previously undiagnosed); laboratory thresholds for exclusion will be as follows: HbA1C ≥6.5%, fasting plasma glucose \>126 mg/dl, or 2 hour value \>200 mg/dl; 5. Receiving treatment for impaired glucose metabolism (i.e., insulin, secretagogues, or other agents to modify peripheral insulin sensitivity or serum glucose concentration); 6. Reduced kidney function (by glomerular filtration rate (GFR \<60 ml/min) or liver function tests (any single LFT ≥ 2.5 times above the upper limit of normal) as determined by test results at screening and any time point of the study; 7. Elevated calcitonin level (as determined at screening to rule out thyroid cancer); 8. Pregnancy or women who may become pregnant during the course of the study, or those who are nursing; 9. Medically unstable; 10. Acute illness or infection; 11. Diminished mental capacity; and 12. Inability or unwillingness of subject to provide informed consent.

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