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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859960
Recruitment Status : Completed
First Posted : March 1, 2019
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Arzu Atici, Fatih Sultan Mehmet Training and Research Hospital

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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Diagnostic Test: body composition Diagnostic Test: glucose, insulin, glycohemoglobin

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.

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Other
Time Perspective: Other
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
Actual Study Start Date : September 21, 2014
Actual Primary Completion Date : May 10, 2018
Actual Study Completion Date : August 8, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: body composition
    fat mass % (FM%) and fat-free mass (FFM%)% of arms, legs, trunk, android, gynoid and total body
    Other Name: dual-energy absorptiometry (DXA),
  • 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.
    Other Name: fasting blood glucose, insulin, glycohemoglobin


Primary Outcome Measures :
  1. Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance [ Time Frame: One day ]
    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).

  2. Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity [ Time Frame: One day ]
    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).

  3. Correlation Between Penn Spasm Frequency Scale and Insulin Resistance [ Time Frame: One day ]
    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).

  4. Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity [ Time Frame: One day ]
    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).

  5. Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass% [ Time Frame: One day ]
    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.

  6. Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass% [ Time Frame: One day ]
    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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859960


Sponsors and Collaborators
Fatih Sultan Mehmet Training and Research Hospital
Investigators
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Principal Investigator: Arzu Atici Fatih Sultan Mehmet Training and Research Hospital
  Study Documents (Full-Text)

Documents provided by Arzu Atici, Fatih Sultan Mehmet Training and Research Hospital:
Study Protocol  [PDF] August 6, 2020
Statistical Analysis Plan  [PDF] August 6, 2020
Informed Consent Form  [PDF] August 6, 2020

Publications:
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Responsible Party: Arzu Atici, Principal Investigator, Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03859960    
Other Study ID Numbers: 2013/22
First Posted: March 1, 2019    Key Record Dates
Results First Posted: September 4, 2020
Last Update Posted: September 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arzu Atici, Fatih Sultan Mehmet Training and Research Hospital:
Body composition
glucose
spasticity
spinal cord injury
Additional relevant MeSH terms:
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Muscle Spasticity
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs