Status:
COMPLETED
Once Weekly GLP-1 in Persons With Spinal Cord Injury
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Collaborating Sponsors:
Kessler Institute for Rehabilitation
Conditions:
Spinal Cord Injuries
Insulin Resistance
Eligibility:
All Genders
18-69 years
Phase:
PHASE4
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 d...
Detailed Description
Obesity is an underlying condition that predisposes to the development of several medical disorders and diseases. It is well appreciated that obesity has reached pandemic proportions in Western societ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Personal history of or family history of medullary thyroid carcinoma;
- History of multiple endocrine neoplasia syndrome type 2;
- History of pancreatitis;
- 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;
- 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.
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03292315
Start Date
October 16 2018
End Date
March 1 2023
Last Update
March 14 2023
Active Locations (1)
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1
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052