Status:
ACTIVE_NOT_RECRUITING
Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation (Columbus)
Lead Sponsor:
AdventHealth Translational Research Institute
Collaborating Sponsors:
Sanford-Burnham Medical Research Institute
Takeda
Conditions:
Obesity
Disorder of Lipid Storage and Metabolism
Eligibility:
All Genders
18-40 years
Phase:
NA
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 effe...
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 mitocho...
Eligibility Criteria
Inclusion
- 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
- /min
- Engaged in a minimum of 1.5 h of moderate to vigorous intensity aerobic exercise 3 times/ week
- Applicable to Group 3
- BMI ≥ 30 kg/m2 and weight ≤ 350 lbs
- Not involved in a regular exercise program
Exclusion
- 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
- Females that are currently or have been pregnant or are currently or have nursed a child within the last 12 months (minimum).
- Parental enrollment into the study that compromises the well being of the child \[no partner or connected caregiver\]
- Unwilling or unable to abstain from caffeine or alcohol 48 hours prior to metabolic rate measurements
- Increased liver function tests
- Metal objects that would interfere with the measurement of body composition /magnetic resonance spectroscopy such as implanted rods, surgical clips, etc
- Any New York Heart Association class of congestive heart failure
- History of deep vein thrombosis or pulmonary embolism
- Significant varicose veins
- Abnormal blood count/Anemia, or blood donation within the last 2 months
- Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
- Bariatric surgery or liposuction within the previous 3 years
- Cancer (active malignancy with or without concurrent chemotherapy)
- Rheumatoid disease
- Bypass graft in limb
- Known genetic factor (Factor V Leiden, etc) or hypercoagulable state
- Diagnosed peripheral arterial or vascular disease, or intermittent claudication
- Family history of primary deep vein thrombosis or pulmonary embolism
- Peripheral neuropathy
- Claustrophobia
- Frequent nocturnal urination and/or sleep apnea
- Presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participants' ability to complete the training protocol
- Applicable to Group 2
- Gait problems
- Major Depression
- Presence of an eating disorder or eating attitudes/behaviors that could interfere with the study completion
- Unwilling or unable to complete the protocol
- Applicable to Group 3
- HbA1c ≥ 6.5% (O)
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01911091
Start Date
July 1 2013
End Date
December 1 2025
Last Update
March 7 2025
Active Locations (1)
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1
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804