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

NCT ID: NCT01911091

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Obesity Disorder of Lipid Storage and Metabolism Lipid Metabolism Disorders Metabolic Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1 - Regular exercise

Alternate interval training and aerobic training and exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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.

Group 2 - Athlete exercise

Athletes are not given any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 3 - Obese No Exercise

The Obese group will not receive intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanford-Burnham Medical Research Institute

OTHER

Sponsor Role collaborator

Takeda

INDUSTRY

Sponsor Role collaborator

AdventHealth Translational Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven R Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Translational Research Institute for Metabolism and Diabetes

Locations

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Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, United States

Site Status

Countries

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United States

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http://www.tri-md.org

Florida Hospital's Translational Research Institute for Metabolism and Diabetes

Other Identifiers

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TRIMDFH 460196

Identifier Type: -

Identifier Source: org_study_id

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