Intermittent Hypoxia 2: Cardiovascular and Metabolism

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.

Conditions

• Hypoxia
• Sleep Apnea
• Obstructive Sleep Apnea

Interventions

DRUG

Placebo

The subjects receive 1 oral pill of placebo each morning during the second week of the two periods, so 14 pills in all.

DRUG

Placebo

The subjects receive 1 oral pill of placebo each morning during the second week of the two periods, so 14 pills in all.

DRUG

Valsartan

The subjects receive 1 oral pill of Valsartan each morning during the second week of the two periods, so 14 pills in all. 1 pill equal 40 mg.

DRUG

Amlodipine

The subjects receive 1 oral pill of Amlodipine each morning during the second week of the two periods, so 14 pills in all. 1 pill equal 6,944 mg of amlodipine besilate with 5 mg of amlodipine.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• University Hospital, Grenoble

  lead OTHER

Principal Investigators

• Renaud RT Tamisier, PhD · University Hospital of Genoble

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-08-07

Primary Completion

2014-07-17

Completion

2017-03-16

Countries

• France

Study Locations