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

This study is ongoing, but not recruiting participants.

First Received: April 23, 2008 Last Updated: February 5, 2009 History of Changes

Sponsors and Collaborators:	Norwegian University of Science and Technology St. Olavs Hospital
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00666094

Purpose

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	Phase
Diabetes Mellitus, Type 2	Behavioral: Exercise	Phase II

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A Randomized Controlled Trial of Strength Versus Aerobic Exercise Training to Improve Glycemic Control in Men With Type 2-Diabetes

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 ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Strength versus endurance

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 will conduct a RCT and invite 30 men with type 2-diabetes to participate. The participants are randomized to either an endurance training group or a strength training group. Both groups will exercise three sessions per week in three months. The training will be supervised. Blood samples will be determined before and after the intervention.

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with type 2-diabetes
Male, 35-70 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

More Information

No publications provided

Responsible Party:	Program of Human movement science, NTNU ( Borge Moe )
Study ID Numbers:	520073168, 520073168
Study First Received:	April 23, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00666094 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Norwegian University of Science and Technology:

Type 2-diabetes, exercise intervention, RCT, Norway

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009