Research with human participants

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Influence of hyperglycaemia and sustained hypoxia on the hypoxic ventilatory response and the hypoxic pulmonary vasoconstriction.

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In this study we want to investigate the effects of sustained hyperglycaemia and hypoxia on the hypoxic pulmonary vasoconstriction and hypoxic ventilatory response

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Diabetic complications
Study type
Interventional

ID

NL-OMON35915

Source

ToetsingOnline

Brief title

Glucose II

Condition

  • Diabetic complications
  • Pulmonary vascular disorders

Synonym

diabetes

Research involving

Human

Sponsors and support

Primary sponsor :
Leids Universitair Medisch Centrum
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
hyperglycaemia, hypoxia, pulmonary pressure, ventilation

Outcome measures

Primary outcome

systolic PAP

HVR

HVD

Secondary outcome

nvt

Background summary

Hypoxia and hyperglycaemia are important factors in the development of
pulmonary diseases. The exact mechanism of the huamn reaction to hypoxia is
unclear. It is clear however that metabolic factors are of great importance.

Study objective

In this study we want to investigate the effects of sustained hyperglycaemia
and hypoxia on the hypoxic pulmonary vasoconstriction and hypoxic ventilatory
response

Study design

Double blinded randomized trial, the subjects will subjected to the protocol
twice (normoglycaemia and hyperglycaemia)

Intervention

hypoxia
hyperglycaemia

Study burden and risks

headache during hypoxia somethimes occurs, which is treated with paracetamol
a bruise may occur on the spot of the iv
hyperglycaemia is tolerated well and has no side effects after such a short
period

Public
Leids Universitair Medisch Centrum

albinusdreef 2
2333 ZA, Leiden
NL
Scientific
Leids Universitair Medisch Centrum

albinusdreef 2
2333 ZA, Leiden
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

The major inclusion criteria are that the subject is healthy and has echo evidence of tricuspid regurgitation during systole, which is not clinically relevant but in fact can be demonstrated in most normal individuals.

Exclusion criteria

Obesity (BMI > 30), Presence of medical disease: heart-, lung-, liver-, kidneydisease; diabetes, Presence of psychiatric disease, History of chronic alcohol or drug use, Possibility of pregnancy, Lactation

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Placebo
Primary purpose :
Other

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
13
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Leiden-Den Haag-Delft (Leiden)

metc-ldd@lumc.nl

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
CCMO NL36320.058.11