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Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)

Primary Purpose

Spinal Cord Injuries, Tetraplegia, Paraplegia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ursolic Acid
Strength Training
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female individuals with paraplegia having chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from T2-T8 Male and female individuals wi4.th chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from C4-C7 Exclusion Criteria: Pregnant or planning to become pregnant Women who are breastfeeding

Sites / Locations

  • University of Miami - Miami Project to Cure ParalysisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

UA and exercise in paraplegia group

UA in tetraplegia group

Arm Description

Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.

Participants will take UA 4 capsules twice daily for 12 weeks

Outcomes

Primary Outcome Measures

Change in muscle mass using Dual X-ray Absorptiometry (DXA)
Changes in muscle mass as measured by Dual X-ray Absorptiometry
Changes in muscle mass using Computed Tomography (CT) scans
Changes in muscle mass as measured by CT scans
Changes in peak isokinetic strength
Peak strength of both arms at 90 degrees of flexion will be tested in elbow flexion and extension on a Biodex dynamometer
Changes in fasting insulin resistance (IR)
Changes in IR using Homeostatic Model of Assessment (HOMA) v2 model estimates steady state beta cell function and insulin sensitivity as percentages of a normal reference population. The change in resting IR will be measured by (fasting serum glucose*fasting serum insulin/22.5). Lower values indicate a higher degree of insulin sensitivity.
Changes in glucose disposal
Changes in glucose disposal will be measured by the Oral Glucose Tolerance Test (OGTT) using Trutol glucose solution of 75 grams. The rates of glucose disposal will be defined by the area under the glucose challenge curve (AUC).

Secondary Outcome Measures

Full Information

First Posted
March 7, 2023
Last Updated
September 18, 2023
Sponsor
University of Miami
Collaborators
Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05776862
Brief Title
Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)
Official Title
A Pilot Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate if Ursolic Acid supplementation may be effective in reducing muscle loss and improving blood sugar control in the SCI community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Tetraplegia, Paraplegia, Muscle Loss, Atrophy, Muscular, Insulin Resistance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UA and exercise in paraplegia group
Arm Type
Experimental
Arm Description
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Arm Title
UA in tetraplegia group
Arm Type
Experimental
Arm Description
Participants will take UA 4 capsules twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ursolic Acid
Intervention Description
Subjects will take an oral 400mg (8 capsules - 4 in the morning/200mg and 4 at night/200mg) supplement of UA every day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Strength Training
Intervention Description
Subjects will perform 3 sets of 10 repetitions of concentric and eccentric upper body exercises (bicep curls and tricep extensions) each session. Each session will last approximately 10-15 minutes of weightlifting with a 2-minute rest period between sets. The arm selected for exercise will be randomized.
Primary Outcome Measure Information:
Title
Change in muscle mass using Dual X-ray Absorptiometry (DXA)
Description
Changes in muscle mass as measured by Dual X-ray Absorptiometry
Time Frame
Baseline, 12 weeks
Title
Changes in muscle mass using Computed Tomography (CT) scans
Description
Changes in muscle mass as measured by CT scans
Time Frame
Baseline, 12 weeks
Title
Changes in peak isokinetic strength
Description
Peak strength of both arms at 90 degrees of flexion will be tested in elbow flexion and extension on a Biodex dynamometer
Time Frame
Baseline, 12 weeks
Title
Changes in fasting insulin resistance (IR)
Description
Changes in IR using Homeostatic Model of Assessment (HOMA) v2 model estimates steady state beta cell function and insulin sensitivity as percentages of a normal reference population. The change in resting IR will be measured by (fasting serum glucose*fasting serum insulin/22.5). Lower values indicate a higher degree of insulin sensitivity.
Time Frame
Baseline, 12 weeks
Title
Changes in glucose disposal
Description
Changes in glucose disposal will be measured by the Oral Glucose Tolerance Test (OGTT) using Trutol glucose solution of 75 grams. The rates of glucose disposal will be defined by the area under the glucose challenge curve (AUC).
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female individuals with paraplegia having chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from T2-T8 Male and female individuals wi4.th chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from C4-C7 Exclusion Criteria: Pregnant or planning to become pregnant Women who are breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Graham, MS
Phone
3052435119
Email
pgraham1@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark S Nash, PhD
Phone
305.243.3628
Email
mnash@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Nash, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami - Miami Project to Cure Paralysis
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark S Nash, PhD
Phone
305-243-3628
Email
mnash@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Patricia Graham, MS, CCRC
Phone
305-243-5119
Email
pgraham1@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Mark S Nash, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)

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