Clinical trial NCT03859960: The Effects of Spasticity on Glucose Metabolism in Individuals With Spinal Cord Injury
Official title: The Effects of Spasticity on Glucose Metabolism and Soft Tissue Body Composition in Individuals With Motor Complete and Motor Incomplete Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Keywords: Body composition
glucose
spasticity
spinal cord injury
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with SCI were included to study if they were 18-65 years old and times from injury were at least one year.

Brief 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.

Eligibility criteria: Inclusion Criteria:

• Spinal cord injury AIS A,B,C,D

Exclusion Criteria:

* Other central nervous system diseases
* Significant complications that affect spasticity
* Joint contracture
* Diabetes mellitus

Primary outcomes:
measure: Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance
timeFrame: One day
measure: Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity
timeFrame: One day
measure: Correlation Between Penn Spasm Frequency Scale and Insulin Resistance
timeFrame: One day
measure: Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity
timeFrame: One day
measure: Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass%
timeFrame: One day
measure: Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass%
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Arzu Atici
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skold C, Levi R, Seiger A. Spasticity after traumatic spinal cord injury: nature, severity, and location. Arch Phys Med Rehabil. 1999 Dec;80(12):1548-57. doi: 10.1016/s0003-9993(99)90329-5.
citation: Gorgey AS, Dudley GA. Spasticity may defend skeletal muscle size and composition after incomplete spinal cord injury. Spinal Cord. 2008 Feb;46(2):96-102. doi: 10.1038/sj.sc.3102087. Epub 2007 Jul 17.
citation: Gorgey AS, Dolbow DR, Dolbow JD, Khalil RK, Castillo C, Gater DR. Effects of spinal cord injury on body composition and metabolic profile - part I. J Spinal Cord Med. 2014 Nov;37(6):693-702. doi: 10.1179/2045772314Y.0000000245. Epub 2014 Jul 7.
citation: Gorgey AS, Dudley GA. Skeletal muscle atrophy and increased intramuscular fat after incomplete spinal cord injury. Spinal Cord. 2007 Apr;45(4):304-9. doi: 10.1038/sj.sc.3101968. Epub 2006 Aug 29.
citation: Gorgey AS, Chiodo AE, Zemper ED, Hornyak JE, Rodriguez GM, Gater DR. Relationship of spasticity to soft tissue body composition and the metabolic profile in persons with chronic motor complete spinal cord injury. J Spinal Cord Med. 2010;33(1):6-15. doi: 10.1080/10790268.2010.11689669.
citation: Jung IY, Kim HR, Chun SM, Leigh JH, Shin HI. Severe spasticity in lower extremities is associated with reduced adiposity and lower fasting plasma glucose level in persons with spinal cord injury. Spinal Cord. 2017 Apr;55(4):378-382. doi: 10.1038/sc.2016.132. Epub 2016 Sep 13.