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Clinical Trials/NCT01911091
NCT01911091
Active, not recruiting
Not Applicable

Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation in Both Skeletal Muscle and Adipose Tissue

AdventHealth Translational Research Institute1 site in 1 country56 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
AdventHealth Translational Research Institute
Enrollment
56
Locations
1
Primary Endpoint
Measure change in mitochondrial capacity
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to collect data to help researchers identify factors, such as certain proteins or genetic codes, that are secreted from muscle that are associated with the beneficial effects of exercise.

Detailed Description

Study Objectives: 1. To identify specific changes in messenger ribonucleic acid (mRNA)/micro ribonucleic acid (miRNA) expression in muscle associated with higher or lower relative measures of mitochondrial capacity and fat oxidation. 2. To identify secreted factors/miRNAs that specifically relate to the metabolic response of muscle and that are present after a single initial bout of exercise. 3. To collect the appropriate clinical samples (muscle and adipose tissue, plasma/serum) to enable validation of myokines associated with changes in oxygen consumption/mitochondrial content via in vivo and in vitro discovery efforts.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
AdventHealth Translational Research Institute
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Applicable to all Groups
  • Healthy men and women, aged 18 - 40, inclusive.
  • Willing to stop alcohol and caffeine consumption for 48 hours preceding each blood draw
  • Applicable to Group 1
  • BMI between 22 and 29.9 kg/m2
  • Not involved in regular exercise program
  • Willing to exercise every day for the study period
  • Applicable to Group 2
  • BMI between 22 and 29.9 kg/m2
  • Maximal oxygen uptake (VO2max) ≥ 45 ml/kg fat-free mass

Exclusion Criteria

  • Applicable to All Groups
  • History of Type 2 Diabetes
  • "Unfavorable anatomy" for continuous venous blood sample collection
  • Abnormal resting ECG
  • Significant renal, cardiac, liver, lung, or neurological disease (controlled hypertension is acceptable if baseline bp \< 140/90 on medications)
  • Use of drugs known to affect energy metabolism or body weight: including, but not limited to: orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
  • Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
  • New onset (\<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy
  • Alcohol or other drug abuse
  • Smoking within the past 3 months

Outcomes

Primary Outcomes

Measure change in mitochondrial capacity

Time Frame: Baseline (Day -6), Day 18

The difference will be measured in obese, lean and athletic participants. The Phosphocreatine (PCr) recovery time constant and the PCr level in oxygenated muscle at rest will be used to calculate maximum mitochondrial capacity.

Secondary Outcomes

  • Measure change of expression of proteins(Baseline (Day -6), Day 0, Day 5, Day 12, Day 18)
  • Measure change in mRNA/miRNA levels(Baseline (Day -6), Day 0, Day 5, Day 12, Day 18)

Study Sites (1)

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