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Glucose II study.


- candidate number10841
- NTR NumberNTR3236
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jan-2012
- Secondary IDsP11.058 / NL35083.058.11; METC LUMC / CCMO
- Public TitleGlucose II study.
- Scientific TitleGlucose II study.
- ACRONYMGlucose II
- hypothesisHyperglycaemia alters the sustained hypoxic pulmonary vasoconstriction (HPV) and the hypoxic ventilatory response (HVR).
- Healt Condition(s) or Problem(s) studiedHypoxia, Pulmonary arterial hypertension, COPD, Diabetes Mellitus
- Inclusion criteriaHealthy volunteers aged 18-45 with echo evidence of tricuspid regurgitation during systole, which is not clinically relevant but in fact can be demonstrated in most normal individuals.
- Exclusion criteria1. Obesity (BMI > 30);
2. Presence of medical disease: heart-, lung-, liver-, kidney- and lung disease; diabetes;
3. Presence of psychiatric disease;
4. History of chronic alcohol or drug use;
5. Possibility of pregnancy;
6. Lactation.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate1-jul-2012
- Target number of participants12
- InterventionsCrossover trial, with randomly a hyperglycaemic (15 mmol/l) hypoxic episode of 60 minutes and a normoglycaemic hypoxic episode of 60 minutes. Hyperglycaemia accomplished according the glucose clamp technique of Defronzo et al. Two episodes at least to weeks apart.
- Primary outcome1. Ventilatory response: We will monitor ventilation continuously and afterwards analyze these data based on acute response as well as non linear modeling;
2. Pulmonary arterial pressure will be estimated using the tricuspid valve maximum gradient, which is a good estimate of the systolic pulmonary arterial pressure, using echocardiography. We will monitor the PAP every minute for the first 20 minutes and thereafter every 5 minutes.
- Secondary outcomeVital and echocardiographic parameters.
- TimepointsEvery minute for the first 20 minutes, hereafter every 5 minutes for the remaining 40 minutes.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. Rob Lindeman
- CONTACT for SCIENTIFIC QUERIESMD. Rob Lindeman
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryThe HVR and HPV are effected by several metabolic processes. In this study we want to investigate whether these reflexes are under direct influence of glucose levels and what the magnitude of the effect is.
- Main changes (audit trail)
- RECORD4-jan-2012 - 29-jan-2012


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