A Randomized Controlled Trial of Exercise Training Among... | NCT00666094

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

NCT00666094

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Feb 9, 2017Estimated

Enrollment

26Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2
Hyperglycemia

Interventions

Endurance training
strength training

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
520073168	Other Identifier	SVT

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008Actual

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Apr 23, 2008

First Submission Date that Met QC Criteria

Apr 23, 2008

First Posted Date

Apr 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2017

Last Update Posted Date

Feb 9, 2017Estimated

Name	Class
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
endurance training	Active Comparator	supervised endurance training	Behavioral: Endurance training
strength training	Experimental	Supervised strength training	Behavioral: strength training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endurance training	Behavioral	supervised endurance training. Three sessions per week in three months.	endurance training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1C		12.01.08

Secondary Outcomes

Measure	Description	Time Frame
body composition, C-peptid, BP, Cholesterol (LDL, HDL), Triglycerides		12.01.08

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

71 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liv B Augestad, PhD	National Taiwan Normal University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NTNU		Trondheim			Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Moe B, Augestad LB, Åsvold BO, Flanders WD. Effects of aerobic versus resistance training on glycaemic control in men with type 2 diabetes. European Journal of Sports Science 11(5): 365-374, 2011

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000076663	Endurance Training
D055070	Resistance Training

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

ID	Term
D003924	Diabetes Mellitus, Type 2
D006943	Hyperglycemia