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

Obesity Clinical Trial

— Columbus  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01911091
• Other study ID #: TRIMDFH 460196
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2013
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: AdventHealth Translational Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: June 2024
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Translational Research Institute for Metabolism and Diabetes	Orlando	Florida

Sponsors (3)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute	Sanford-Burnham Medical Research Institute, Takeda

Country where clinical trial is conducted

United States, 

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* Note: There are 82 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure change in mitochondrial capacity	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.	Baseline (Day -6), Day 18
Secondary	Measure change of expression of proteins	The difference will be measured in obese, lean and athletic participants.; This will be taken from muscle biopsy and/or blood plasma samples obtained at baseline, before and after exercise.	Baseline (Day -6), Day 0, Day 5, Day 12, Day 18
Secondary	Measure change in mRNA/miRNA levels	The difference will be measured in obese, lean and athletic participants.; This will be taken from muscle biopsy and/or blood plasma samples obtained at baseline, before and after exercise.	Baseline (Day -6), Day 0, Day 5, Day 12, Day 18

External Links

•   Florida Hospital's Translational Research Institute for Metabolism and Diabetes