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

NCT ID: NCT03859960

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-21
• Study Completion Date: 2018-08-08

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.

Conditions

Spinal Cord Injuries

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

body composition

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

Intervention Type: DIAGNOSTIC_TEST

glucose, insulin, glycohemoglobin

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

dual-energy absorptiometry (DXA),; fasting blood glucose, insulin, glycohemoglobin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Arzu Atici

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arzu Atici

Role: PRINCIPAL_INVESTIGATOR

Fatih Sultan Mehmet Training and Research Hospital

References

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.

Reference Type: BACKGROUND

PMID: 10597805 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17637764 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25001559 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16940987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20397439 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27618974 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2013/22

Identifier Type: -

Identifier Source: org_study_id