NCT00945165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 25, 2012

Status Verified

October 1, 2012

Enrollment Period

2.8 years

First QC Date

July 23, 2009

Last Update Submit

October 24, 2012

Conditions

Diabetes Mellitus, Type 2Hyperglycemia

Keywords

Continuous Glucose Monitoring SystemExercise

Outcome Measures

Primary Outcomes (1)

  • Hyperglycemia

    24h

Secondary Outcomes (1)

  • Mean Blood Glucose

    24h

Study Arms (2)

Exercise

EXPERIMENTAL
Behavioral: Exercise intervention

No exercise

EXPERIMENTAL
Behavioral: No exercise

Interventions

Exercise interventionBEHAVIORAL

various exercise characteristics

Exercise
No exerciseBEHAVIORAL

No exercise control period

No exercise

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • BMI 25 - 35 kg/m2
  • Insulin therapy
  • diagnosed with type 2 diabetes \>2 yr
  • Cardiac disease (cardiac event in the last 5 years)
  • HbA1c \>10%
  • Type 2 diabetes patients on oral blood glucose lowering medication
  • BMI 25 - 35 kg/m2
  • diagnosed with type 2 diabetes \>2 yr
  • Cardiac disease (cardiac event in the last 5 years)
  • HbA1c \>10%
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 24583293DERIVED

  • 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.

    PMID: 24041682DERIVED

  • 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.

    PMID: 22399700DERIVED

  • 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.

    PMID: 22124605DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HyperglycemiaMotor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Jan-Willem M van Dijk, MSc

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

July 1, 2009

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

October 25, 2012

Record last verified: 2012-10

Locations

NL(1)