Clinical Trials Directory

Trials / Completed

CompletedNCT03859960

The Effects of Spasticity on Glucose Metabolism in Individuals With Spinal Cord Injury

The Effects of Spasticity on Glucose Metabolism and Soft Tissue Body Composition in Individuals With Motor Complete and Motor Incomplete Spinal Cord Injury

Status
Completed
Phase
Study type
Observational
Enrollment
33 (actual)
Sponsor
Fatih Sultan Mehmet Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Muscle atrophy may occur in individuals with spinal cord injury (SCI) as a result of diminished physical activity and alterations in glucose metabolism and body composition may be seen. In a few studies, it has been suggested that spasticity may have a positive impact on glucose metabolism by preventing muscle atrophy and alterations in body composition in individuals with motor complete SCI. Investigators aimed to assess the effects of spasticity on glucose metabolism and body composition in participants with complete and incomplete SCI.

Detailed description

Investigators plan a prospective clinical trial. Participants with SCI were included to study if times from injury were at least one year. Participants had an AIS grades of A-D with spasticity. We evaluated that participants with AIS A and B SCI were motor complete group, AIS C and D SCI were motor incomplete group. Spasticity was assessed with Modified Ashworth Scale (MAS) and spasms were assessed with Penn Spasm Frequency Scale (PSFS). Hip adductor and extensor spasticity, knee extensor and flexor spasticity and ankle plantar flexor spasticity were assessed by using MAS. Body composition was measured by dual-energy x-ray absorptiometry. All participants underwent a 75 gram (g) oral glucose tolerance test (OGTT). Insulin sensitivity was assessed by calculating Matsuda index and HOMA-IR. Investigators assessed the effects of spasticity on glucose metabolism and body composition in participants with SCI.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTbody compositionfat mass % (FM%) and fat-free mass (FFM%)% of arms, legs, trunk, android, gynoid and total body
DIAGNOSTIC_TESTglucose, insulin, glycohemoglobinIn the morning after 12 hours overnight fast, all individuals underwent a 75 gram (g) oral glucose tolerance test (OGTT). Blood samples were taken before loading glucose and then 30, 60, 90 and 120 minutes after taking glucose solution in order to measure serum glucose and insulin levels. Glycohemoglobin (HbA1c) was measured in blood samples taken before the OGTT. We calculated the Matsuda index and Homeostasis model assessment index (HOMA-IR) using glucose and insulin levels.

Timeline

Start date
2014-09-21
Primary completion
2018-05-10
Completion
2018-08-08
First posted
2019-03-01
Last updated
2020-09-04
Results posted
2020-09-04

Source: ClinicalTrials.gov record NCT03859960. Inclusion in this directory is not an endorsement.