CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
body composition +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03859960
NCT03859960N/ACompleted
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The Effects of Spasticity on Glucose Metabolism and Soft Tissue Body Composition in Individuals With Motor Complete and Motor Incomplete Spinal Cord Injury

Fatih Sultan Mehmet Training and Research Hospital·observational·Posted Mar 1, 2019·Updated Sep 4, 2020

In Brief

An observational study evaluating body composition and glucose, insulin, glycohemoglobin for Spinal Cord Injuries. Completed, enrolled 33 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injuries
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 1, 2019
Enrollment StartSep 21, 2014
Primary CompletionMay 10, 2018
Study CompletionAug 8, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.3 years ago

Interventions

body compositionother

fat mass % (FM%) and fat-free mass (FFM%)% of arms, legs, trunk, android, gynoid and total body

glucose, insulin, glycohemoglobinother

In 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.