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

University of Miami10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries Tetraplegia Paraplegia Muscle Loss Atrophy, Muscular Insulin Resistance

Interventions

Ursolic AcidDRUG

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.

Strength TrainingOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami - Miami Project to Cure Paralysis

Miami, Florida, United States

Outcomes

Primary Outcomes

Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA)

Changes in muscle mass in grams as measured by Dual X-ray Absorptiometry

Time frame: Baseline, 12 weeks

Changes in Peak Isokinetic Strength

Peak strength (peak torque in ft-lb) of both arms at 90 degrees range of motion will be tested in elbow flexion and extension (at 60 deg/s) on a Biodex dynamometer

Time frame: Baseline, 12 weeks

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.

Time frame: Baseline, 12 weeks

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).

Time frame: Baseline, 12 weeks

Data from ClinicalTrials.gov

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