Exercise and Glycemic Control in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945165
• Other study ID #: 09-3-028
• Status: Completed
• Phase: N/A
• First received: July 23, 2009
• Last updated: October 24, 2012
• Start date: July 2009
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hyperglycemia

Intervention

Behavioral:
• Exercise intervention
various exercise characteristics
• No exercise
No exercise control period

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperglycemia		24h	No
Secondary	Mean Blood Glucose		24h	No

External Links

•   Website Muscle Metabolism Maastricht