Clinical trial NCT00945165: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hyperglycemia
Keywords: Continuous Glucose Monitoring System
Exercise
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2009-07-24
Enrollment: 124
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hyperglycemia
timeFrame: 24h
Secondary outcomes:
measure: Mean Blood Glucose
timeFrame: 24h
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht UMC
name: Jan-Willem M van Dijk, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.