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Exercise and Glycemic Control in Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2, Hyperglycemia

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Exercise intervention

No exercise

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Continuous Glucose Monitoring System, Exercise

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Exercise

No exercise

Arm Description

Outcomes

Primary Outcome Measures

Hyperglycemia

Secondary Outcome Measures

Mean Blood Glucose

Full Information

NCT ID

NCT00945165

First Posted

July 23, 2009

Last Updated

October 24, 2012

Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT00945165

Brief Title

Exercise and Glycemic Control in Type 2 Diabetes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Hyperglycemia

Keywords

Continuous Glucose Monitoring System, Exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Title

No exercise

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Exercise intervention

Intervention Description

various exercise characteristics

Intervention Type

Behavioral

Intervention Name(s)

No exercise

Intervention Description

No exercise control period

Primary Outcome Measure Information:

Title

Hyperglycemia

Time Frame

24h

Secondary Outcome Measure Information:

Title

Mean Blood Glucose

Time Frame

24h

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan-Willem M van Dijk, MSc

Organizational Affiliation

Maastricht UMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University Medical Centre

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6200 MD

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

24583293

Citation

Klinkenberg LJ, van Dijk JW, Tan FE, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Circulating cardiac troponin T exhibits a diurnal rhythm. J Am Coll Cardiol. 2014 May 6;63(17):1788-95. doi: 10.1016/j.jacc.2014.01.040. Epub 2014 Feb 26.

Results Reference

derived

PubMed Identifier

24041682

Citation

van Dijk JW, Venema M, van Mechelen W, Stehouwer CD, Hartgens F, van Loon LJ. Effect of moderate-intensity exercise versus activities of daily living on 24-hour blood glucose homeostasis in male patients with type 2 diabetes. Diabetes Care. 2013 Nov;36(11):3448-53. doi: 10.2337/dc12-2620. Epub 2013 Sep 16.

Results Reference

derived

PubMed Identifier

22399700

Citation

van Dijk JW, Tummers K, Stehouwer CD, Hartgens F, van Loon LJ. Exercise therapy in type 2 diabetes: is daily exercise required to optimize glycemic control? Diabetes Care. 2012 May;35(5):948-54. doi: 10.2337/dc11-2112. Epub 2012 Mar 7.

Results Reference

derived

PubMed Identifier

22124605

Citation

van Dijk JW, Manders RJ, Tummers K, Bonomi AG, Stehouwer CD, Hartgens F, van Loon LJ. Both resistance- and endurance-type exercise reduce the prevalence of hyperglycaemia in individuals with impaired glucose tolerance and in insulin-treated and non-insulin-treated type 2 diabetic patients. Diabetologia. 2012 May;55(5):1273-82. doi: 10.1007/s00125-011-2380-5. Epub 2011 Nov 29.

Results Reference

derived

Links:

URL

http://www.m3-research.nl

Description

Website Muscle Metabolism Maastricht

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Exercise and Glycemic Control in Type 2 Diabetes

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