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

NCT03859960 | Completed Results

• 1 other identifier: 2013/22
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries

Keywords

Body composition; glucose; spasticity; spinal cord injury

Outcome Measures

Primary Outcomes (6)

• Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance

  Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. HOMA index was used to evaluate insulin resistance. HOMA index is a simple, and inexpensive method used for evaluating insulin sensitivity. In most of the studies, values \>2.7 were accepted as insulin resistance. HOMA-IR was calculated by using fasting plasma glucose (mg/dL) X fasting insulin (uIU/mL) /405 formula. Pearson correlation was used to calculate the correlation coefficient (r).

  One day

• Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity

  We used the Matsuda index to assess insulin sensitivity. Matsuda index was calculated 10.000/square root (Fasting plasma glucose x fasting plasma insulin) x (mean OGTT glucose concentration X mean OGTT insulin concentration) formula. Higher scores mean better. Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r).

  One day

• Correlation Between Penn Spasm Frequency Scale and Insulin Resistance

  Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. HOMA index is a simple, and inexpensive method used for evaluating insulin sensitivity. In most of the studies, values \>2.7 were accepted as insulin resistance. HOMA-IR was calculated by using fasting plasma glucose (mg/dL) X fasting insulin (uIU/mL) /405 formula. Pearson correlation was used to calculate the correlation coefficient (r).

  One day

• Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity

  We used the Matsuda index to assess insulin sensitivity. Matsuda index was calculated 10.000/square root (Fasting plasma glucose x fasting plasma insulin) x (mean OGTT glucose concentration X mean OGTT insulin concentration) formula. Higher scores mean better. Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r).

  One day

• Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass%

  The body composition of the individuals was measured by dual-energy absorptiometry (DXA) device. Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. Pearson correlation was used to calculate correlation coefficient.

  One day

• Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass%

  The body composition of the individuals was measured by dual-energy absorptiometry (DXA) device. Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r).

  One day

Interventions

body composition DIAGNOSTIC_TEST

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

Also known as: dual-energy absorptiometry (DXA),

glucose, insulin, glycohemoglobin DIAGNOSTIC_TEST

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.

Also known as: fasting blood glucose, insulin, glycohemoglobin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Spinal cord injury AIS A,B,C,D

You may not qualify if:

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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Related Publications (6)

• 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.

  PMID: 10597805 BACKGROUND

• 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.

  PMID: 17637764 BACKGROUND

• 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.

  PMID: 25001559 BACKGROUND

• 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.

  PMID: 16940987 BACKGROUND

• 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.

  PMID: 20397439 BACKGROUND

• 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.

  PMID: 27618974 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity

Interventions

Body Composition; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Physiological Phenomena; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: MD. Arzu Atici
• Organization: Fatih Sultan Mehmet Education and Research Hospital

arzususinatici@gmail.com

+905335621208

Study Officials

• Arzu Atici

  Fatih Sultan Mehmet Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 1, 2019
• Study Start: September 21, 2014
• Primary Completion: May 10, 2018
• Study Completion: August 8, 2018
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share