Back to resultsACTIV- Exercise Intervention in Healthy Young Men
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Insulin Resistance
Eligibility Criteria
Inclusion Criteria:
T2DM group:
- Men aged 25-35
- BMI > 30 kg/m2
- Sedentary lifestyle determined by activity index questionnaire (not involved in regular exercise program) and accelerometer data.
- Are willing to eat only foods provided by Pennington for the study period
Diagnosed with T2DM defined by one or more of the following:
- fasting plasma glucose > 126 mg/dL at entry
- a two-hour OGTT glucose > 200mg/dL
- current medication for T2DM
Obese group:
- Men aged 25-35
- BMI > 30 kg/m2
- Sedentary lifestyle activity index questionnaire (not involved in regular exercise program) and accelerometer data.
- Are willing to eat only foods provided by Pennington for the study period
FH+ group:
- Men aged 25-35
- One parent diagnosed with T2DM
- fasting insulin > 10mIU/ml (> 50th %tile)
- BMI between 22 and 30 kg/m2
- Sedentary lifestyle activity index questionnaire (not involved in regular exercise program) and accelerometer data.
- Are willing to exercise every day for the study period
- Are willing to eat only foods provided by Pennington for the study period
FH- group:
- Men aged 25-35
- Parents and grandparents were not diagnosed with T2DM
- Fasting insulin < 10mIU/ml (< 50th %tile)
- BMI between 22 and 30 kg/m2
- Sedentary lifestyle activity index questionnaire (not involved in regular exercise program) and accelerometer data.
- Are willing to exercise for the study period
- Are willing to eat only foods provided by Pennington for the study period
Athlete group:
- Men aged 25-35
- Maximal oxygen uptake > 60 ml/kg.min
- Are engaged in minimum of 1.5 h of aerobic exercise 3 times/ week
- Are willing to eat only foods provided by Pennington for the study period
Exclusion Criteria:
- Abnormal resting or exercise 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
- Alcohol or other drug abuse
- Smoking
- Gait problems
- Unwilling or unable to abstain from caffeine (48h) prior to metabolic rate measurements
- Unwilling or unable to eat all study foods
- Increased liver function tests at baseline (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)
- Metal objects that would interfere with the measurement of body composition /MRS such as implanted rods, surgical clips, etc
- NYHA class III/IV CHF is an exclusionary cardiac condition
- history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- varicose veins
- major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
- 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 DVT or PE (pulmonary embolism)
- peripheral neuropathy
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
To compare/ contrast the power of skeletal muscle biopsy vs. MRS to detect differences in mitochondrial capacity
Secondary Outcome Measures
To compare mitochondrial changes in response to exercise in subjects FH - vs. FH + subjects by skeletal muscle biopsy and MRS
To determine if HFD impairs mitochondrial changes in response to exercise in the FH + group by muscle biopsy and MRS.
To determine the role of mitochondrial capacity in metabolic flexibility and insulin sensitivity
Full Information
NCT ID
NCT00401791
First Posted
November 17, 2006
Last Updated
September 16, 2022
Sponsor
Pennington Biomedical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00401791
Brief Title
ACTIV- Exercise Intervention in Healthy Young Men
Official Title
"ACTIV"Validation of a Paradigm for the Evaluation of Compounds That Activate Mitochondrial Biogenesis in Skeletal Muscle
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pennington Biomedical Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is designed to compare muscle energy capacity in men with obesity or diabetes as compared to athletes. This study will also enable researchers to determine whether MRS can replace muscle biopsy for this type of assessment.
Detailed Description
Skeletal muscle mitochondrial defects are a sine qua non of insulin resistance in patients with type 2 diabetes mellitus (T2DM), obese and subjects with family history of T2DM (FH+). Exercise increases mitochondrial capacity whereas lipid infusion or high fat diet decreases genes involved in mitochondrial biogenesis. In this study 2 cohorts will be involved: Cohort I (athletes, T2DM and obese) and Cohort II (healthy with "FH+" or without "FH-" family history of T2DM). This randomized, parallel arm clinical trial will consist of 4 periods: screening, stabilization (3 days), baseline (for Cohort I and II) and exercise period (14 days, only for Cohort II). The overall objective of the study is to validate a paradigm for the evaluation of compounds and drugs that activate mitochondrial biogenesis in skeletal muscle. In Specific Aim 1 we will compare and contrast biopsy and MRS power to detect differences in mitochondrial capacity in 78 subjects: athletes (N=10), FH- (N=24), FH+ (N=24), obese (N=10) and T2DM (N=10). In Specific Aim 2 we will compare mitochondrial changes in response to exercise in subjects FH - vs. FH + subjects. In Specific Aim 3 we will determine if HFD impairs mitochondrial changes in response to exercise in FH+ subjects. In Specific Aim 4 we will determine the role of mitochondrial capacity in metabolic flexibility and insulin sensitivity in T2DM, obese, FH+, FH- and athlete subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Aerobic and interval exercise training
Intervention Description
Interval Exercise Training: Each interval training session will start with 10 minutes of warm up and will end with 10 minutes of cool down period at 40% VO2 peak. Training duration, intensity and number of exercise bout will increase with the progression of training period
Aerobic training: Each endurance training session will start with 5 minutes of warm up and will end with 5 minutes of cool down at 40% VO2 peak. Subjects will exercise at 70% VO2 peak for 45 minutes on day 3 and 5, for 55 minutes on day 8 and 10, and for 35 minutes on day 14 using a bicycle ergometer.
Primary Outcome Measure Information:
Title
To compare/ contrast the power of skeletal muscle biopsy vs. MRS to detect differences in mitochondrial capacity
Time Frame
baseline and after intervention
Secondary Outcome Measure Information:
Title
To compare mitochondrial changes in response to exercise in subjects FH - vs. FH + subjects by skeletal muscle biopsy and MRS
Time Frame
baseline and after intervention
Title
To determine if HFD impairs mitochondrial changes in response to exercise in the FH + group by muscle biopsy and MRS.
Time Frame
baseline and after intervention
Title
To determine the role of mitochondrial capacity in metabolic flexibility and insulin sensitivity
Time Frame
baseline and after intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
T2DM group:
Men aged 25-35
BMI > 30 kg/m2
Sedentary lifestyle determined by activity index questionnaire (not involved in regular exercise program) and accelerometer data.
Are willing to eat only foods provided by Pennington for the study period
Diagnosed with T2DM defined by one or more of the following:
fasting plasma glucose > 126 mg/dL at entry
a two-hour OGTT glucose > 200mg/dL
current medication for T2DM
Obese group:
Men aged 25-35
BMI > 30 kg/m2
Sedentary lifestyle activity index questionnaire (not involved in regular exercise program) and accelerometer data.
Are willing to eat only foods provided by Pennington for the study period
FH+ group:
Men aged 25-35
One parent diagnosed with T2DM
fasting insulin > 10mIU/ml (> 50th %tile)
BMI between 22 and 30 kg/m2
Sedentary lifestyle activity index questionnaire (not involved in regular exercise program) and accelerometer data.
Are willing to exercise every day for the study period
Are willing to eat only foods provided by Pennington for the study period
FH- group:
Men aged 25-35
Parents and grandparents were not diagnosed with T2DM
Fasting insulin < 10mIU/ml (< 50th %tile)
BMI between 22 and 30 kg/m2
Sedentary lifestyle activity index questionnaire (not involved in regular exercise program) and accelerometer data.
Are willing to exercise for the study period
Are willing to eat only foods provided by Pennington for the study period
Athlete group:
Men aged 25-35
Maximal oxygen uptake > 60 ml/kg.min
Are engaged in minimum of 1.5 h of aerobic exercise 3 times/ week
Are willing to eat only foods provided by Pennington for the study period
Exclusion Criteria:
Abnormal resting or exercise 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
Alcohol or other drug abuse
Smoking
Gait problems
Unwilling or unable to abstain from caffeine (48h) prior to metabolic rate measurements
Unwilling or unable to eat all study foods
Increased liver function tests at baseline (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)
Metal objects that would interfere with the measurement of body composition /MRS such as implanted rods, surgical clips, etc
NYHA class III/IV CHF is an exclusionary cardiac condition
history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
varicose veins
major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
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 DVT or PE (pulmonary embolism)
peripheral neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Smith, M.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26171795
Citation
Covington JD, Noland RC, Hebert RC, Masinter BS, Smith SR, Rustan AC, Ravussin E, Bajpeyi S. Perilipin 3 Differentially Regulates Skeletal Muscle Lipid Oxidation in Active, Sedentary, and Type 2 Diabetic Males. J Clin Endocrinol Metab. 2015 Oct;100(10):3683-92. doi: 10.1210/JC.2014-4125. Epub 2015 Jul 14.
Results Reference
derived
PubMed Identifier
23818429
Citation
Bajpeyi S, Myrland CK, Covington JD, Obanda D, Cefalu WT, Smith SR, Rustan AC, Ravussin E. Lipid in skeletal muscle myotubes is associated to the donors' insulin sensitivity and physical activity phenotypes. Obesity (Silver Spring). 2014 Feb;22(2):426-34. doi: 10.1002/oby.20556. Epub 2013 Sep 10.
Results Reference
derived
PubMed Identifier
23676496
Citation
Gan Z, Rumsey J, Hazen BC, Lai L, Leone TC, Vega RB, Xie H, Conley KE, Auwerx J, Smith SR, Olson EN, Kralli A, Kelly DP. Nuclear receptor/microRNA circuitry links muscle fiber type to energy metabolism. J Clin Invest. 2013 Jun;123(6):2564-75. doi: 10.1172/JCI67652. Epub 2013 May 8.
Results Reference
derived
PubMed Identifier
21307136
Citation
Bajpeyi S, Pasarica M, Moro C, Conley K, Jubrias S, Sereda O, Burk DH, Zhang Z, Gupta A, Kjems L, Smith SR. Skeletal muscle mitochondrial capacity and insulin resistance in type 2 diabetes. J Clin Endocrinol Metab. 2011 Apr;96(4):1160-8. doi: 10.1210/jc.2010-1621. Epub 2011 Feb 9.
Results Reference
derived
PubMed Identifier
19887595
Citation
Costford SR, Bajpeyi S, Pasarica M, Albarado DC, Thomas SC, Xie H, Church TS, Jubrias SA, Conley KE, Smith SR. Skeletal muscle NAMPT is induced by exercise in humans. Am J Physiol Endocrinol Metab. 2010 Jan;298(1):E117-26. doi: 10.1152/ajpendo.00318.2009. Epub 2009 Nov 3.
Results Reference
derived
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ACTIV- Exercise Intervention in Healthy Young Men
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