|- candidate number||10230|
|- NTR Number||NTR3019|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-aug-2011|
|- Secondary IDs||11-3-019 METC|
|- Public Title||Effects of weight loss on stimulated lipolysis.|
|- Scientific Title||Effects of weight loss on adipose tissue β2-AR-stimulated lipolysis: Role of adipose tissue
oxidative stress and hypoxia.|
|- hypothesis||Moderate weight loss increases sensitivity to β2-AR-stimulated lipolysis in isolated adipocytes from subcutaneous adipose tissue biopsies.|
|- Healt Condition(s) or Problem(s) studied||Obesity, Lipolysis, Beta2-adrenergic sensitivity|
|- Inclusion criteria||1. All subjects entering the Co-Eur programme;|
2. Age > 18 years old;
3. No more than 3 kg weight change in the past 3 months.
|- Exclusion criteria||1. Smoking;|
3. (Medicinal) use of β-blockers or β-agonists;
4. Pregnant women;
5. Blood clotting problems or (medicinal) use of anticoagulantia.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2011|
|- planned closingdate||1-jan-2013|
|- Target number of participants||37|
|- Interventions||Subjects follow the standard weight loss programme in Heerlen (NL) provided by CO-EUR without interference by the researchers. |
CO-EUR is an obesity treatment centre which uses an 18-month-lasting programme with a multi-disciplinary approach, including diet, physical activity and behaviour change, to treat people with obesity.
|- Primary outcome||Changes in sensitivity to β2-AR-stimulated lipolysis in adipocytes isolated from subcutaneous adipose tissue biopsies.
|- Secondary outcome||1. Changes in markers of adipose tissue hypoxia;|
2. Changes in markers of adipose tissue and systemic oxidative stress.
|- Timepoints||1. Premeasurements will be done before the start of the CO-EUR programme;|
2. Postmeasurements will be done after 9 months of participation in the CO-EUR programme. Postmeasurements will be done in every subject, who is still participating in the Co-Eur programme after 9 months, regardless of the amount of weight lost or gained in those 9 months.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. K.F.M. Teunissen-Beekman|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. M.A. Baak, van|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|University Maastricht (UM)|
|- Brief summary||This study investigates the effects of weight loss on beta2-adrenergic stimulated lipolysis in isolated adipocytes. In addition the effects of weight loss on adipose tissue hypoxia and adipose tissue and systemic oxidative stress will be determined.|
|- Main changes (audit trail)|
|- RECORD||10-aug-2011 - 4-sep-2011|