Once Weekly GLP-1 in Persons With Spinal Cord Injury

What Was Tested

The trial (phase 4) is built around Semaglutide for insulin resistance, prediabetes & type 2 diabetes.

Chronic spinal cord injury (SCI) results in adverse soft tissue body composition changes and an extremely sedentary lifestyle.

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.

It had two arms (groups): one (experimental) and No Intervention (other).

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

The registry classes the interventions as drug and other.

More on the Plan

It is well appreciated that obesity has reached pandemic proportions in Western societies.

Excess adipose tissue is assumed to play an integral role in the pathogenesis of vascular dysfunction and the development of T2DM (Lau, Dhillon, Yan, Szmitko, \& Verma, 2005).

During the acute and chronic phases of SCI, marked adverse changes occur in soft tissue body composition and associated carbohydrate and lipid metabolism.

The primary approach to treat T2DM in the general population is diet and exercise (i.e., lifestyle modification).

Who Took Part

Enrollment: 5 actual participants took part.

It was open to people of any sex aged from 18 years up to 69 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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);. Insulin Resistant as determined at screening: (FPI, ≥15 µU/ml); -OR-. Pre-diabetic, as determined by any one of the following:.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: personal history of or family history of medullary thyroid carcinoma;; history of multiple endocrine neoplasia syndrome type 2;; history of pancreatitis;.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2018-10-16 with completion listed for 2020-03-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Body Weight (time frame: Baseline, Week 13, Week 26). Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) (time frame: Baseline, Week 13, Week 26). Homeostatic Model Assessment of Beta-Cell Function (HOMA-B) (time frame: Baseline, Week 13, Week 26).

It also tracked 2 secondary outcomes, for example Body Fat and Glycated Hemoglobin (HbA1C).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 5 people with insulin resistance, prediabetes & type 2 diabetes.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Insulin resistance, prediabetes & type 2 diabetes research.