No registrations found.
ID
Source
Brief title
Health condition
hypoxia, pulmonary hypertension, COPD, diabetes,
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. 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 outcome
Vital and echocardiographic parameters.
Background summary
The 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.
Study objective
Hyperglycaemia alters the sustained hypoxic pulmonary vasoconstriction (HPV) and the hypoxic ventilatory response (HVR).
Study design
Every minute for the first 20 minutes, hereafter every 5 minutes for the remaining 40 minutes.
Intervention
Crossover 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.
LUMC, P5-Q
Rob Lindeman
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
c.r.lindeman@lumc.nl
LUMC, P5-Q
Rob Lindeman
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
c.r.lindeman@lumc.nl
Inclusion criteria
Healthy 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3088 |
| NTR-old | NTR3236 |
| Other | METC LUMC / CCMO : P11.058 / NL35083.058.11; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |