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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014