Exercise and Glycemic Control in Type 2 Diabetes | NCT00945165

Studies
Exercise and Glycemic Control in Type 2 Diabetes

NCT00945165

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Oct 25, 2012Estimated

Enrollment

124Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2
Hyperglycemia

Interventions

Exercise intervention
No exercise

Countries

Netherlands

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

Status Module

Record Verification Date

Oct 2012

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

Jul 2009

Primary Completion Date

Apr 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jul 23, 2009

First Submission Date that Met QC Criteria

Jul 23, 2009

First Posted Date

Jul 24, 2009Estimated

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

Oct 24, 2012

Last Update Posted Date

Oct 25, 2012Estimated

Name	Class
ZonMw: The Netherlands Organisation for Health Research and Development	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

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.

Detailed Description

Not provided

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

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Experimental		Behavioral: Exercise intervention
No exercise	Experimental		Behavioral: No exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise intervention	Behavioral	various exercise characteristics	Exercise

Measure	Description	Time Frame
Hyperglycemia		24h

Measure	Description	Time Frame
Mean Blood Glucose		24h

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 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
Jan-Willem M van Dijk, MSc	Maastricht UMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Centre		Maastricht	Limburg	6200 MD	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24583293	Derived	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.
24041682	Derived	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.

ID	Term
D003924	Diabetes Mellitus, Type 2
D006943	Hyperglycemia
D009043	Motor Activity

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