NCT00401791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 21, 2022

Status Verified

January 1, 2016

Enrollment Period

2.1 years

First QC Date

November 17, 2006

Last Update Submit

September 16, 2022

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

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

    baseline and after intervention

Secondary Outcomes (3)

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

    baseline and after intervention

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

    baseline and after intervention

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

    baseline and after intervention

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Exercise

2

NO INTERVENTION

Interventions

ExerciseBEHAVIORAL

* 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.

Also known as: Aerobic and interval exercise training
1

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • +20 more criteria

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (5)

  • 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.

    PMID: 26171795DERIVED

  • 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.

    PMID: 23818429DERIVED

  • 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.

    PMID: 23676496DERIVED

  • 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.

    PMID: 21307136DERIVED

  • 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.

    PMID: 19887595DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Steven R Smith, M.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 22, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2008

Study Completion

October 1, 2016

Last Updated

September 21, 2022

Record last verified: 2016-01

Locations

US(1)