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NCT01911091Active, not recruiting

Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation (Columbus)

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

Source: ClinicalTrials.gov · Last updated 30 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
56 (estimated)
First submitted
24 Jul 2013
Start date
Jul 2013
Primary completion date
Dec 2014
Lead sponsor
AdventHealth Translational Research Institute
Diseases
Obesity
NCT number
NCT01911091

What you commit to

  • Study type: Interventional
  • Planned participants: 56
  • From Jul 2013 to the primary completion date, Dec 2014
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of drugs known to affect energy metabolism or body weight: including, but not limited to: orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
  • New onset (\<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy
  • Alcohol or other drug abuse
  • Unwilling or unable to abstain from caffeine or alcohol 48 hours prior to metabolic rate measurements
  • Metal objects that would interfere with the measurement of body composition /magnetic resonance spectroscopy such as implanted rods, surgical clips, etc
  • 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)

Other illness

  • History of Type 2 Diabetes
  • Significant renal, cardiac, liver, lung, or neurological disease (controlled hypertension is acceptable if baseline bp \< 140/90 on medications)
  • Any New York Heart Association class of congestive heart failure
  • History of deep vein thrombosis or pulmonary embolism
  • Rheumatoid disease
  • Diagnosed peripheral arterial or vascular disease, or intermittent claudication
  • Family history of primary deep vein thrombosis or pulmonary embolism
  • 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
  • Presence of an eating disorder or eating attitudes/behaviors that could interfere with the study completion

Lab values

  • Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
  • Abnormal blood count/Anemia, or blood donation within the last 2 months
  • HbA1c ≥ 6.5% (O)

Other

  • Applicable to All Groups
  • "Unfavorable anatomy" for continuous venous blood sample collection
  • Abnormal resting ECG
  • 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 \[no partner or connected caregiver\]
  • Increased liver function tests
  • Significant varicose veins
  • Bypass graft in limb
  • Known genetic factor (Factor V Leiden, etc) or hypercoagulable state
  • Peripheral neuropathy
  • Claustrophobia
  • Frequent nocturnal urination and/or sleep apnea
  • Gait problems
  • Major Depression
  • Unwilling or unable to complete the protocol
    • Applicable to Group 3

Who the study is looking for

  • 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

Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Translational Research Institute for Metabolism and Diabetes
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.