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Exercise and Glycemic Control in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00945165
First received: July 23, 2009
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Hyperglycemia
 Behavioral: Exercise intervention
Behavioral: No exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Defining the Optimal Exercise Program to Improve Glycemic Control in Various Stages of Type 2 Diabetes.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Hyperglycemia [ Time Frame: 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Blood Glucose [ Time Frame: 24h ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: July 2009
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Behavioral: Exercise intervention
various exercise characteristics
Experimental: No exercise Behavioral: No exercise
No exercise control period

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945165

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Jan-Willem M van Dijk, MSc Maastricht UMC
  More Information

Additional Information:
Website Muscle Metabolism Maastricht  This link exits the ClinicalTrials.gov site

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00945165     History of Changes
Other Study ID Numbers: 09-3-028
Study First Received: July 23, 2009
Last Updated: October 24, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Continuous Glucose Monitoring System
Exercise

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 May 16, 2013