Once Weekly GLP-1 in Persons With Spinal Cord Injury

NCT03292315 | Completed Phase 4 FDA Drug

• 1 other identifier: BAU-17-038
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Insulin Resistance; Pre Diabetes; Obesity

Keywords

Glucagon-Like Peptide-1

Outcome Measures

Primary Outcomes (3)

• Body Weight

  Efficacy of GLP-1 to reduce total body weight determined by Dual Energy Absorptiometry (DXA)

  Baseline, Week 13, Week 26

• Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  Efficacy of GLP-1 to reduce HOMA-IR

  Baseline, Week 13, Week 26

• Homeostatic Model Assessment of Beta-Cell Function (HOMA-B)

  Efficacy of GLP-1 to increase HOMA-B

  Baseline, Week 13, Week 26

Secondary Outcomes (2)

• Body Fat

  Baseline, Week 13, Week 26

• Glycated Hemoglobin (HbA1C)

  Baseline, Week 13, Week 26

Study Arms (2)

Semaglutide 1MG Injection [Ozempic]

EXPERIMENTAL

20 subjects will be randomized to receive once weekly injection of Semaglutide (Ozempic1mg) for 26 weeks.

Drug: Semaglutide 1MG Injection [Ozempic]

No Intervention

OTHER

10 subjects will be randomized to receive no intervention for 26 weeks.

Other: No Intervention

Interventions

Semaglutide 1MG Injection [Ozempic] DRUG

Once weekly injection of 1mg of Semaglutide.

Semaglutide 1MG Injection [Ozempic]

No Intervention OTHER

No injection will be administered

No Intervention

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 to 69;
• Chronic (e.g., duration of injury greater than 3 years) stable SCI (regardless of level of neurological injury);
• ASIA A-D (non-ambulatory defined as not able to weight bear for more than 20% of the day);
• Obese Percent Body Fat defined as \> 25% for men and \> 35% for women (as determined by screening DXA scan);
• Insulin Resistant as determined at screening: (FPI, ≥15 µU/ml); -OR-
• Pre-diabetic, as determined by any one of the following:
• HbA1C ≥ 5.7% and \< 6.4%; or
• 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

You may not qualify if:

• Personal history of or family history of medullary thyroid carcinoma;
• History of multiple endocrine neoplasia syndrome type 2;
• History of pancreatitis;
• Receiving treatment for impaired glucose metabolism (i.e., insulin, secretagogues, or other agents to modify peripheral insulin sensitivity or serum glucose concentration);
• 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;
• Elevated calcitonin level (as determined at screening to rule out thyroid cancer);
• Pregnancy or women who may become pregnant during the course of the study, or those who are nursing;
• Medically unstable;
• Acute illness or infection;
• Diminished mental capacity; and
• Inability or unwillingness of subject to provide informed consent.

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead
• Kessler Institute for Rehabilitation: collaborator

Study Sites (1)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

Related Publications (1)

• Cirnigliaro CM, La Fountaine MF, Sauer SJ, Cross GT, Kirshblum SC, Bauman WA. 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. J Spinal Cord Med. 2024 Jul;47(4):597-604. doi: 10.1080/10790268.2023.2207064. Epub 2023 May 9.

  PMID: 37158751 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Insulin Resistance; Glucose Intolerance; Obesity

Interventions

semaglutide; Injections

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Investigator, National Center for the Medical Consequences of Spinal Cord Injury

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: October 16, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)