Intermittent Hypoxia 2: Cardiovascular and Metabolism

• Status: Terminated
• Trial end date: 2017-03-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare cardiovascular physiological adaptation to intermittent hypoxia (IH) of nonobese healthy subjects. The exposure will be two periods of two weeks (IH versus exposure "placebo hypoxia"). The investigators will use pharmacological tools, peripheral vasodilator (amlodipine) or specific blocker of angiotensin receptor (valsartan) versus the taking of a placebo. The allocation of the tool and the exhibition will be randomized (HI / placebo, valsartan / amlodipine). The outcome measures evaluated concern the cardiovascular system, systemic inflammation and tissular and glucose metabolism.

The investigators assume an increase in arterial resistance during the intermittent hypoxia compared to the control group, these being dependent on sympathetic tone.

The investigators hypothesize that the metabolic alterations that will be observed after experimental simulation (IH and fragmentation of sleep for 15 consecutive nights) will be less severe in the valsartan group than in the amlodipine group in comparison with the placebo group.

A serum bank and a gene bank will be performed for the requirements of subsequent studies if necessary.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Amlodipine; Valsartan

Criteria

Inclusion Criteria:

• Healthy subject

• Subject aged of 18 years-old at least

• Diagnostic AHI<15/h and <5% of total sleep time spent with a SaO2<90%

• Free and informed consent signed

• Subject covered by social security

• Negative pregnancy test

Exclusion Criteria:

• Subject with a medical pathology (respiratory, cardiovascular, renal, metabolic, neurological...)

• Tobacco consumption > 5 cigarettes/days

• Alcohol consumption > 3 units/days (1 unit=1 drink)

• Subject under trusteeship or guardianship

• Subject unaffiliated with the social security

• Person deprived of their liberty, adult protected by laws, person hospitalized

• Ongoing participation in another clinical research study

• Subject non-cooperative or respectful of obligations inherent in the participation in the study