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

Insulin Resistance Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776862
• Other study ID #: 20221142
• Secondary ID: COPBC
• Status: Recruiting
• Phase: Phase 2
• Start date: March 27, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Patricia Graham, MS
• Phone: 3052435119
• Email: pgraham1[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male and female individuals with paraplegia having chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from T2-T8

2. Male and female individuals wi4.th chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from C4-C7

Exclusion Criteria:

1. Pregnant or planning to become pregnant

2. Women who are breastfeeding

Related Conditions & MeSH terms

• Atrophy, Muscular
• Insulin Resistance
• Muscle Loss
• Muscular Atrophy
• Paraplegia
• Quadriplegia
• Spinal Cord Injuries
• Tetraplegia
• Wounds and Injuries

Intervention

Drug:
• Ursolic Acid
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.

Other:
• Strength Training
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.

Locations

Country	Name	City	State
United States	University of Miami - Miami Project to Cure Paralysis	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle mass using Dual X-ray Absorptiometry (DXA)	Changes in muscle mass as measured by Dual X-ray Absorptiometry	Baseline, 12 weeks
Primary	Changes in muscle mass using Computed Tomography (CT) scans	Changes in muscle mass as measured by CT scans	Baseline, 12 weeks
Primary	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	Baseline, 12 weeks
Primary	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.	Baseline, 12 weeks
Primary	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).	Baseline, 12 weeks