NCT01218256

Brief Summary

Skeletal muscle accounts for up to 40% of the total body weight and is responsible for approximately 75% of the whole body insulin-stimulated glucose uptake. Resistance training has been shown to improve insulin-stimulated glucose uptake in patients with T2DM. Therefore the investigators aim to compose the effects of 2 different resistance training protocols in combination with aerobic endurance training (AET) on muscle strength, muscle mass and glycemic control in type 2 diabetes mellitus patients (T2DM). The investigators aim to perform an 8 week randomized controlled training intervention in 32 T2DM patients. Patients will be randomly assigned to AET (cycle ergometer, 60-70% of heart rate reserve) combined with hypertrophy resistance training (HRT, n=16, 2 sets, 10-12 repetitions, 70% of the one-repetition maximum) or with endurance resistance training (ERT, n=16, 2 sets, 25-30 repetitions, 40% of the one-repetition maximum). Body composition, blood analyses, physical work capacity and muscle strength will be measured pre- and post-intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_1 type-2-diabetes-mellitus

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

July 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
Last Updated

October 11, 2010

Status Verified

June 1, 2007

Enrollment Period

1.4 years

First QC Date

October 8, 2010

Last Update Submit

October 8, 2010

Conditions

Keywords

diabetes mellitustype 2 diabetesT2DMresistance traininghypertrophy trainingendurance training

Outcome Measures

Primary Outcomes (1)

  • Muscle strength

    Measruement will be performed using Concept Dyno 2

    8 weeks

Secondary Outcomes (2)

  • Muscle mass

    8 weeks

  • Glycemic control

    8 weeks

Study Arms (2)

Hypertrophy resistance training

ACTIVE COMPARATOR

Aerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus.

Other: Physical exercise training

Endurance resistance training

ACTIVE COMPARATOR

Aerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus.

Other: Physical exercise training

Interventions

aerobic endurance training (cycle ergometer, 60-70% heart rate reserve) hypertrophy resistance training (2sets, 10-12 repetitions, 70% of the one-repetition maximum) endurance resistance training (2 sets, 25-30 repetitions, 40% of the one-repetition maximum)

Also known as: training intervention, resistance training
Endurance resistance trainingHypertrophy resistance training

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes mellitus

You may not qualify if:

  • myocardial infarction within the last 6 months
  • unstable angina pectoris
  • left ventricular ejection fraction less than 40%
  • orthopedic limitations that eliminate to perform resistance training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University

Salzburg, 5020, Austria

Location

Related Publications (9)

  • Maiorana A, O'Driscoll G, Cheetham C, Dembo L, Stanton K, Goodman C, Taylor R, Green D. The effect of combined aerobic and resistance exercise training on vascular function in type 2 diabetes. J Am Coll Cardiol. 2001 Sep;38(3):860-6. doi: 10.1016/s0735-1097(01)01439-5.

    PMID: 11527646BACKGROUND
  • Cauza E, Hanusch-Enserer U, Strasser B, Ludvik B, Metz-Schimmerl S, Pacini G, Wagner O, Georg P, Prager R, Kostner K, Dunky A, Haber P. The relative benefits of endurance and strength training on the metabolic factors and muscle function of people with type 2 diabetes mellitus. Arch Phys Med Rehabil. 2005 Aug;86(8):1527-33. doi: 10.1016/j.apmr.2005.01.007.

    PMID: 16084803BACKGROUND
  • Castaneda F, Layne JE, Castaneda C. Skeletal muscle sodium glucose co-transporters in older adults with type 2 diabetes undergoing resistance training. Int J Med Sci. 2006;3(3):84-91. doi: 10.7150/ijms.3.84. Epub 2006 May 17.

    PMID: 16761076BACKGROUND
  • Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.

    PMID: 11559268BACKGROUND
  • Dunstan DW. Aerobic exercise and resistance training for the management of type 2 diabetes mellitus. Nat Clin Pract Endocrinol Metab. 2008 May;4(5):250-1. doi: 10.1038/ncpendmet0790. Epub 2008 Mar 25. No abstract available.

    PMID: 18364704BACKGROUND
  • Sigal RJ, Kenny GP, Boule NG, Wells GA, Prud'homme D, Fortier M, Reid RD, Tulloch H, Coyle D, Phillips P, Jennings A, Jaffey J. Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Sep 18;147(6):357-69. doi: 10.7326/0003-4819-147-6-200709180-00005.

    PMID: 17876019BACKGROUND
  • Ibanez J, Gorostiaga EM, Alonso AM, Forga L, Arguelles I, Larrion JL, Izquierdo M. Lower muscle strength gains in older men with type 2 diabetes after resistance training. J Diabetes Complications. 2008 Mar-Apr;22(2):112-8. doi: 10.1016/j.jdiacomp.2007.06.008.

    PMID: 18280441BACKGROUND
  • Tokmakidis SP, Zois CE, Volaklis KA, Kotsa K, Touvra AM. The effects of a combined strength and aerobic exercise program on glucose control and insulin action in women with type 2 diabetes. Eur J Appl Physiol. 2004 Aug;92(4-5):437-42. doi: 10.1007/s00421-004-1174-6.

    PMID: 15232701BACKGROUND
  • Ibanez J, Izquierdo M, Arguelles I, Forga L, Larrion JL, Garcia-Unciti M, Idoate F, Gorostiaga EM. Twice-weekly progressive resistance training decreases abdominal fat and improves insulin sensitivity in older men with type 2 diabetes. Diabetes Care. 2005 Mar;28(3):662-7. doi: 10.2337/diacare.28.3.662.

    PMID: 15735205BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Josef Niebauer, MD, PhD, MBA

    Paracelsus Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 11, 2010

Study Start

July 1, 2007

Primary Completion

December 1, 2008

Study Completion

May 1, 2009

Last Updated

October 11, 2010

Record last verified: 2007-06

Locations