Exercise and Glycemic Control in Type 2 Diabetes

October 24, 2012 updated by: Maastricht University Medical Center

Defining the Optimal Exercise Program to Improve Glycemic Control in Various Stages of Type 2 Diabetes.

Hyperglycemia is an independent risk factor for the development of diabetic complications in type 2 diabetes. Exercise improves glycemic control, however, the role of exercise characteristics (e.g. intensity, type of exercise, timing, frequency) remains to be elucidated.

This study aims to assess the effect of several exercise characteristics on hyperglycemia in various subgroups of type 2 diabetes patiënts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200 MD
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Impaired glucose tolerant subjects

Inclusion Criteria:

  • BMI 25 - 35 kg/m2
  • Impaired Glucose Tolerant (according to ADA guidelines)

Exclusion Criteria:

  • Cardiac disease (cardiac event in the last 5 years)
  • Type 2 diabetes
  • Use of orale blood glucose lowering medication or exogenous insulin
  • HbA1c >10%

Insulin treated type 2 diabetes patients

Inclusion Criteria:

  • BMI 25 - 35 kg/m2
  • Insulin therapy
  • diagnosed with type 2 diabetes >2 yr

Exclusion Criteria:

  • Cardiac disease (cardiac event in the last 5 years)
  • HbA1c >10%

Type 2 diabetes patients on oral blood glucose lowering medication

Inclusion Criteria:

  • BMI 25 - 35 kg/m2
  • diagnosed with type 2 diabetes >2 yr

Exclusion Criteria:

  • Cardiac disease (cardiac event in the last 5 years)
  • HbA1c >10%
  • use of exogenous insulin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Behavioral: Exercise intervention
various exercise characteristics
Experimental: No exercise
Behavioral: No exercise
No exercise control period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hyperglycemia
Time Frame: 24h
24h

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Blood Glucose
Time Frame: 24h
24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Jan-Willem M van Dijk, MSc, Maastricht UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (Estimate)

July 24, 2009

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

October 24, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-3-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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