Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/02/2008
Date assigned
21/04/2008
Last edited
09/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luc van Loon

ORCID ID

Contact details

Universiteitssingel 50
Maastricht
6229 ER
Netherlands
+31 (0)43 388 1397
l.vanloon@hb.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of long-term exercise training intensity on glycaemic control in type two diabetes patients

Acronym

ITIIRO trial

Study hypothesis

Low- and moderate-to-high intensity exercise training are equally effective for improving glycaemic control in obese, type two diabetes patients.

Ethics approval

Ethics approval received from the Research Ethics Committee of the Virga Jesse Hospital, Hasselt (Belgium) on the 25th November 2004 (ref: 04.38/cardio04.05).

Study design

Randomised two armed clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Type two diabetes mellitus

Intervention

All patients were subjected to eight weeks of endurance exercise training, three days each week, one subgroup at high intensity while the other at low intensity. Pharmacological treatment and caloric intake were not changed. All patients were followed for eight weeks.

Other sponsors:
1. Vrije Universiteit Brussel (Belgium)
Pleinlaan 2
Brussels
B-3500
Belgium
Website: http://www.vub.ac.be

2. Virga Jesse Hospital (Belgium)
Stadomvaart 11
Hasselt
B-3500
Belgium
Email: rego@virgajesse.be
Website: http://www.virgajesse.be

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Body composition
2. Blood plasma parameters
3. Exercise performance capacity

All measurements were made at 0 and 8 weeks of exercise training.

Secondary outcome measures

1. Skeletal muscle biopsy parameters
2. Physical activity level
3. Food intake

All measurements were made at 0 and 8 weeks of exercise training.

Overall trial start date

10/12/2003

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Obese, male, type two diabetes patients (at least one year diagnosed with disease)
2. Have not participated in physical activity programs or caloric intake restriction programs for at least two years ahead of study
3. Aged 40 - 75 years

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

50

Participant exclusion criteria

1. Exogenous insulin use
2. Cardiac/renal/pulmonary diseases

Recruitment start date

10/12/2003

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Belgium

Trial participating centre

Universiteitssingel 50
Maastricht
6229 ER
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (The Netherlands)

Sponsor details

Postbus 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

http://www.unimaas.nl

Funders

Funder type

University/education

Funder name

Maastricht University (Netherlands)

Alternative name(s)

Maastricht University, UM

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Funder name

The Heart Centre of Hasselt (Hartcentrum Hasselt) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19370339
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22949030

Publication citations

  1. Results

    Hansen D, Dendale P, Jonkers RA, Beelen M, Manders RJ, Corluy L, Mullens A, Berger J, Meeusen R, van Loon LJ, Continuous low- to moderate-intensity exercise training is as effective as moderate- to high-intensity exercise training at lowering blood HbA(1c) in obese type 2 diabetes patients., Diabetologia, 2009, 52, 9, 1789-1797, doi: 10.1007/s00125-009-1354-3.

  2. Results

    Shaw CS, Shepherd SO, Wagenmakers AJ, Hansen D, Dendale P, van Loon LJ, Prolonged exercise training increases intramuscular lipid content and perilipin 2 expression in type I muscle fibers of patients with type 2 diabetes., Am. J. Physiol. Endocrinol. Metab., 2012, 303, 9, E1158-65, doi: 10.1152/ajpendo.00272.2012.

Additional files

Editorial Notes