AzTrials
AzTrials

Insulin ResistanceNCT00401791

ACTIV- Exercise Intervention in Healthy Young Men

A study testing Exercise in people with Insulin Resistance, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Insulin Resistance
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Nov 2006to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
Show all 35Show fewer
  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: "ACTIV"Validation of a Paradigm for the Evaluation of Compounds That Activate Mitochondrial Biogenesis in Skeletal Muscle

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.

Read the 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.

Being tested
Exercise
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Also called Aerobic and interval exercise training

    • 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.
Study groups in NCT00401791
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Behavioral: Exercise
2No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare/ contrast the power of skeletal muscle biopsy vs. MRS to detect differences in mitochondrial capacity

    Measured: baseline and after intervention

Secondary outcomes (3)

  1. To compare mitochondrial changes in response to exercise in subjects FH - vs. FH + subjects by skeletal muscle biopsy and MRS

    Measured: baseline and after intervention

  2. To determine if HFD impairs mitochondrial changes in response to exercise in the FH + group by muscle biopsy and MRS.

    Measured: baseline and after intervention

  3. To determine the role of mitochondrial capacity in metabolic flexibility and insulin sensitivity

    Measured: baseline and after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionDec 2008
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401791
Sponsor's protocol ID
PBRC 26029
Status last verified
Jan 2016
First submitted
17 Nov 2006
Last updated
21 Sep 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26171795

  • 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.

    PubMed 23818429

  • 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.

    PubMed 23676496

  • 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.

    PubMed 21307136

  • 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.

    PubMed 19887595

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Insulin Resistance, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare/ contrast the power of skeletal muscle biopsy vs. MRS to detect differences in mitochondrial capacity (time frame: baseline and after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401791, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022; AzTrials last refreshed its copy on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in