NCT00727779

Brief Summary

Prevention and treatment strategies for diabetes use exercise as the cornerstone. Even though endurance training and strength training both improve insulin resistance, strength training may be better suited for persons at risk for type 2 diabetes. We will expand our pilot studies of muscle adaptation induced by resistance exercise training to determine the biochemical mechanisms that will cause people with the Metabolic Syndrome to secure major benefit from intense strength training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

5.4 years

First QC Date

July 31, 2008

Last Update Submit

February 13, 2015

Conditions

Keywords

diabetes, metabolic syndrome, type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • euglycemic clamp steady state glucose infusion rate (clamp GIR)

    pre- post- intervention

Secondary Outcomes (1)

  • GLUT4 content of muscle

    pre- post- intervention

Study Arms (2)

metabolic syndrome

EXPERIMENTAL

intervention is to undergo eight weeks of progressive strength training; metabolic syndrome subjects will have baseline and post-intervention assessments including muscle biopsies and insulin clamps

Behavioral: strength training

control subjects

ACTIVE COMPARATOR

intervention is to undergo eight weeks of progressive strength training; non-obese sedentary subjects will have the same assessments as the metabolic syndrome subjects and exercise training simultaneously.

Behavioral: strength training

Interventions

eight weeks of progressively increasing resistance training will be done in both groups side-by-side

control subjectsmetabolic syndrome

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • obese family history of diabetes

You may not qualify if:

  • non-obese diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Tennessee State Univ

Johnson City, Tennessee, 37614, United States

Location

Related Publications (10)

  • Stuart CA, Yin D, Howell ME, Dykes RJ, Laffan JJ, Ferrando AA. Hexose transporter mRNAs for GLUT4, GLUT5, and GLUT12 predominate in human muscle. Am J Physiol Endocrinol Metab. 2006 Nov;291(5):E1067-73. doi: 10.1152/ajpendo.00250.2006. Epub 2006 Jun 27.

    PMID: 16803853BACKGROUND
  • Reeds DN, Stuart CA, Perez O, Klein S. Adipose tissue, hepatic, and skeletal muscle insulin sensitivity in extremely obese subjects with acanthosis nigricans. Metabolism. 2006 Dec;55(12):1658-63. doi: 10.1016/j.metabol.2006.08.006.

    PMID: 17142140BACKGROUND
  • Stuart CA, Howell ME, Yin D. Overexpression of GLUT5 in diabetic muscle is reversed by pioglitazone. Diabetes Care. 2007 Apr;30(4):925-31. doi: 10.2337/dc06-1788. Epub 2007 Jan 24.

    PMID: 17251278BACKGROUND
  • Moorman J, Zhang Y, Liu B, LeSage G, Chen Y, Stuart C, Prayther D, Yin D. HIV-1 gp120 primes lymphocytes for opioid-induced, beta-arrestin 2-dependent apoptosis. Biochim Biophys Acta. 2009 Aug;1793(8):1366-71. doi: 10.1016/j.bbamcr.2009.05.007. Epub 2009 May 27.

    PMID: 19477204BACKGROUND
  • Copland JA, Pardini AW, Wood TG, Yin D, Green A, Bodenburg YH, Urban RJ, Stuart CA. IGF-1 controls GLUT3 expression in muscle via the transcriptional factor Sp1. Biochim Biophys Acta. 2007 Nov-Dec;1769(11-12):631-40. doi: 10.1016/j.bbaexp.2007.08.002. Epub 2007 Sep 4.

  • Layne AS, Nasrallah S, South MA, Howell ME, McCurry MP, Ramsey MW, Stone MH, Stuart CA. Impaired muscle AMPK activation in the metabolic syndrome may attenuate improved insulin action after exercise training. J Clin Endocrinol Metab. 2011 Jun;96(6):1815-26. doi: 10.1210/jc.2010-2532. Epub 2011 Apr 20.

  • Stuart CA, Ross IR, Howell ME, McCurry MP, Wood TG, Ceci JD, Kennel SJ, Wall J. Brain glucose transporter (Glut3) haploinsufficiency does not impair mouse brain glucose uptake. Brain Res. 2011 Apr 12;1384:15-22. doi: 10.1016/j.brainres.2011.02.014.

  • Stuart CA, Howell ME, Cartwright BM, McCurry MP, Lee ML, Ramsey MW, Stone MH. Insulin resistance and muscle insulin receptor substrate-1 serine hyperphosphorylation. Physiol Rep. 2014 Dec 3;2(12):e12236. doi: 10.14814/phy2.12236. Print 2014 Dec 1.

  • Stuart CA, South MA, Lee ML, McCurry MP, Howell ME, Ramsey MW, Stone MH. Insulin responsiveness in metabolic syndrome after eight weeks of cycle training. Med Sci Sports Exerc. 2013 Nov;45(11):2021-9. doi: 10.1249/MSS.0b013e31829a6ce8.

  • Stuart CA, McCurry MP, Marino A, South MA, Howell ME, Layne AS, Ramsey MW, Stone MH. Slow-twitch fiber proportion in skeletal muscle correlates with insulin responsiveness. J Clin Endocrinol Metab. 2013 May;98(5):2027-36. doi: 10.1210/jc.2012-3876. Epub 2013 Mar 20.

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusDiabetes Mellitus, Type 2

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Charles A Stuart, MD

    East Tennessee State University, Johnson City, TN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Internal Medicine

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 4, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations