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A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00666094
First received: April 23, 2008
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

To test the hypothesis that there is no difference in change in HbA1C among men with type 2-diabetes after an exercise intervention with strength versus endurance training.


Condition Intervention
Diabetes Mellitus, Type 2
Hyperglycemia
Behavioral: Endurance training
Behavioral: strength training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Strength Versus Aerobic Exercise Training to Improve Glycemic Control in Men With Type 2-diabetes

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • HbA1C [ Time Frame: 12.01.08 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body composition, C-peptid, BP, Cholesterol (LDL, HDL), Triglycerides [ Time Frame: 12.01.08 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: August 2008
Estimated Study Completion Date: July 2014
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: endurance training
supervised endurance training
Behavioral: Endurance training
supervised endurance training. Three sessions per week in three months.
Other Name: Aerobic training
Experimental: strength training
Supervised strength training
Behavioral: strength training
Supervised strength training. Three sessions per week in three months.

Detailed Description:

Exercise training is well documented as part of effective treatment for type 2-diabetes patients. Endurance training has been suggested as the most suitable form of exercise. There are reasons to believe that strength training also has a positive effect. However, comparisons of endurance training and strength training regimes are limited.

Therefore we randomized 26 men with type 2-diabetes to either an endurance training group or a strength training group. Both groups exercised three sessions per week for three months. The training was supervised.

  Eligibility

Ages Eligible for Study:   35 Years to 71 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2-diabetes
  • Male, 35-71 years
  • Managing their diabetes through a lifestyle and/or the drug metformin only
  • Able to participate in either of the exercise groups

Exclusion Criteria:

  • Symptomatic cardiovascular disease
  • Uncontrolled hypertension
  • Physical or cognitive disabilities that will interfere with participating in the exercise regimes.
  • Trained consistently during the last six months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666094

Locations
Norway
NTNU
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Liv B Augestad, PhD NTNU
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00666094     History of Changes
Other Study ID Numbers: 520073168, 520073168
Study First Received: April 23, 2008
Last Updated: October 8, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
Type 2-diabetes
exercise therapy
RCT
Norway

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014