Should type two diabetes patients exercise at high or low intensity levels for the improvement of glycaemic control?

ISRCTN ISRCTN32206301
DOI https://doi.org/10.1186/ISRCTN32206301
Secondary identifying numbers N/A
Submission date
11/02/2008
Registration date
21/04/2008
Last edited
09/01/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Luc van Loon
Scientific

Universiteitssingel 50
Maastricht
6229 ER
Netherlands

Phone +31 (0)43 388 1397
Email l.vanloon@hb.unimaas.nl

Study information

Study designRandomised two armed clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffects of long-term exercise training intensity on glycaemic control in type two diabetes patients
Study acronymITIIRO trial
Study objectivesLow- and moderate-to-high intensity exercise training are equally effective for improving glycaemic control in obese, type two diabetes patients.
Ethics approval(s)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).
Health condition(s) or problem(s) studiedType two diabetes mellitus
InterventionAll 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 typeOther
Primary outcome measure1. Body composition
2. Blood plasma parameters
3. Exercise performance capacity

All measurements were made at 0 and 8 weeks of exercise training.
Secondary outcome measures1. Skeletal muscle biopsy parameters
2. Physical activity level
3. Food intake

All measurements were made at 0 and 8 weeks of exercise training.
Overall study start date10/12/2003
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants50
Key inclusion criteria1. 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
Key exclusion criteria1. Exogenous insulin use
2. Cardiac/renal/pulmonary diseases
Date of first enrolment10/12/2003
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Belgium
  • Netherlands

Study participating centre

Universiteitssingel 50
Maastricht
6229 ER
Netherlands

Sponsor information

University Maastricht (UM) (The Netherlands)
University/education

Postbus 616
Maastricht
6200 MD
Netherlands

Website http://www.unimaas.nl
ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

University/education

Maastricht University (Netherlands)
Private sector organisation / Universities (academic only)
Alternative name(s)
Maastricht University, UM
Location
Netherlands
The Heart Centre of Hasselt (Hartcentrum Hasselt) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2009 Yes No
Results article results 01/11/2012 Yes No