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ACTIV- Exercise Intervention in Healthy Young Men

This study has been completed.
Sponsor:
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00401791
First received: November 17, 2006
Last updated: February 5, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Insulin Resistance
 Behavioral: Exercise
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: "ACTIV"Validation of a Paradigm for the Evaluation of Compounds That Activate Mitochondrial Biogenesis in Skeletal Muscle

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • To compare/ contrast the power of skeletal muscle biopsy vs. MRS to detect differences in mitochondrial capacity [ Time Frame: baseline and after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine the role of mitochondrial capacity in metabolic flexibility and insulin sensitivity [ Time Frame: baseline and after intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: November 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Exercise
  • 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.
Other Name: Aerobic and interval exercise training
No Intervention: 2

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.

  Eligibility

Ages Eligible for Study:   25 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401791

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Steven R Smith, M.D. Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven R Smith, Pennigton Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00401791     History of Changes
Other Study ID Numbers: PBRC26029
Study First Received: November 17, 2006
Last Updated: February 5, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013