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Secondary Prevention in Type 2 Diabetes: Comparison of Two Different Resistance Exercise Training Protocols

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Physical exercise training
Sponsored by
Paracelsus Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes mellitus, type 2 diabetes, T2DM, resistance training, hypertrophy training, endurance training

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • type 2 diabetes mellitus

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hypertrophy resistance training

Endurance resistance training

Arm Description

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

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

Outcomes

Primary Outcome Measures

Muscle strength
Measruement will be performed using Concept Dyno 2

Secondary Outcome Measures

Muscle mass
Muscle mass will be measured using dual X-ray absorbiotometry
Glycemic control
Fasting blood glucose, HbA1c, and fructosamin will be measured using routine laboratory methods

Full Information

First Posted
October 8, 2010
Last Updated
October 8, 2010
Sponsor
Paracelsus Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01218256
Brief Title
Secondary Prevention in Type 2 Diabetes: Comparison of Two Different Resistance Exercise Training Protocols
Official Title
Combined Resistance and Endurance Training in Patients With Type 2 Diabetes: A Pilot-study to Assess the Effects of 2 Different Resistance Protocols on Muscle Mass, Strength and Glycemic Control.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Paracelsus Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes mellitus, type 2 diabetes, T2DM, resistance training, hypertrophy training, endurance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertrophy resistance training
Arm Type
Active Comparator
Arm Description
Aerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus.
Arm Title
Endurance resistance training
Arm Type
Active Comparator
Arm Description
Aerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus.
Intervention Type
Other
Intervention Name(s)
Physical exercise training
Other Intervention Name(s)
training intervention, resistance training
Intervention Description
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)
Primary Outcome Measure Information:
Title
Muscle strength
Description
Measruement will be performed using Concept Dyno 2
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Muscle mass
Description
Muscle mass will be measured using dual X-ray absorbiotometry
Time Frame
8 weeks
Title
Glycemic control
Description
Fasting blood glucose, HbA1c, and fructosamin will be measured using routine laboratory methods
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 2 diabetes mellitus Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Niebauer, MD, PhD, MBA
Organizational Affiliation
Paracelsus Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University
City
Salzburg
ZIP/Postal Code
5020
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
11527646
Citation
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.
Results Reference
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PubMed Identifier
16084803
Citation
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.
Results Reference
background
PubMed Identifier
16761076
Citation
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.
Results Reference
background
PubMed Identifier
11559268
Citation
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.
Results Reference
background
PubMed Identifier
18364704
Citation
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.
Results Reference
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PubMed Identifier
17876019
Citation
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.
Results Reference
background
PubMed Identifier
18280441
Citation
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.
Results Reference
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PubMed Identifier
15232701
Citation
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.
Results Reference
background
PubMed Identifier
15735205
Citation
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.
Results Reference
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Links:
URL
http://www.salk.at/sportmedizin.html
Description
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University

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Secondary Prevention in Type 2 Diabetes: Comparison of Two Different Resistance Exercise Training Protocols

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