This trial is active, not recruiting.

Conditions obesity, disorder of lipid storage and metabolism, lipid metabolism disorders, metabolic disorder
Treatment exercise
Sponsor Translational Research Institute for Metabolism and Diabetes, Florida
Collaborator Sanford-Burnham Medical Research Institute
Start date July 2013
End date December 2014
Trial size 56 participants
Trial identifier NCT01911091, TRIMDFH 460196


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Alternate interval training and aerobic training and exercise
A 5-minute warm-up and a 5-minute cool-down prior to and following each exercise session, respectively. There will be alternating days of interval training and aerobic training. The interval training will be performed on an upright stationary bike, while the aerobic training will be performed on a treadmill. The interval training will consist of five-minute bouts of higher intensity alternated with 4 minutes of lower intensity for a total duration of 45 minutes. Intensity will increase each week. The aerobic training component will be fixed at a moderate intensity, but will increase in duration each week from 45 minutes to 75 minutes to 90 minutes during the third and final week.
(No Intervention)
Athletes are not given any intervention
(No Intervention)
The Obese group will not receive intervention

Primary Outcomes

Measure change in mitochondrial capacity
time frame: Baseline (Day -6), Day 18

Secondary Outcomes

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

Eligibility Criteria

All participants from 18 years up to 40 years old.

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 /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 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 - 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)

Additional Information

Official title Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation in Both Skeletal Muscle and Adipose Tissue
Principal investigator Steven R Smith, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Translational Research Institute for Metabolism and Diabetes, Florida.