|
Welcome
|
|
25 July 2008
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Should type two diabetes patients exercise at high or low intensity levels for the improvement of glycaemic control? |
| ISRCTN | ISRCTN32206301 |
| ClinicalTrials.gov identifier | |
| Public title | Should type two diabetes patients exercise at high or low intensity levels for the improvement of glycaemic control? |
| Scientific title | Effects of long-term exercise training intensity on glycaemic control in type two diabetes patients |
| Acronym | ITIIRO trial |
| Serial number at source | N/A |
| 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 |
| Countries of recruitment | Belgium |
| Disease/condition/study domain | Type two diabetes mellitus |
| Participants - 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 |
| Participants - exclusion criteria |
1. Exogenous insulin use
2. Cardiac/renal/pulmonary diseases |
| Anticipated start date | 10/12/2003 |
| Anticipated end date | 31/12/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 50 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
1. Skeletal muscle biopsy parameters
2. Physical activity level 3. Food intake All measurements were made at 0 and 8 weeks of exercise training. |
| Sources of funding |
1. Maastricht University (The Netherlands)
2. The Heart Centre of Hasselt (Hartcentrum Hasselt) (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr Luc van Loon |
| Address | Universiteitssingel 50 |
| City/town | Maastricht |
| Zip/Postcode | 6229 ER |
| Country | Netherlands |
| Tel | +31 (0)43 388 1397 |
| Fax | +31 (0)43 367 0972 |
| l.vanloon@hb.unimaas.nl | |
| Sponsor | University Maastricht (UM) (The Netherlands) |
| Address | Postbus 616 |
| City/town | Maastricht |
| Zip/Postcode | 6200 MD |
| Country | Netherlands |
| Sponsor website: | http://www.unimaas.nl |
| Date applied | 11/02/2008 |
| Last edited | 21/04/2008 |
| Date ISRCTN assigned | 21/04/2008 |
|
|
|
| © ISRCTN | |
|
|
|
|