Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-12-31

Brief Summary

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The primary objectives are to compare the mean levels of the sleep quality parameters of subjects : with a nocturnal fall of the SBP (Systolic blood pressure), DBP (diastolic blood pressure) and MAP (mean arterial pressure) over of egal to 10% (dipping subjects) and of subjects with a nocturnal fall of SBP, DBP and MAP inferior to 10% (non dipper subjects).

The secondary objectives are :

Establish correlations between:

* The quality of sleep parameters
* The parameters of BP variations between the diurnal and nocturnal periods and the awake periods of sleep defined in reference to polysomnography.
* The glycemia levels on 24h with a glycemic holter. The parameters of the sympathic system activation evaluated in reference to the measure of the baroreflex sensibility during the awake period.

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Detailed Description

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It is a prospective monocentric study after a preliminary period of depistage of the sleep abnormalities by oximetry at home. The patient would be hospitalized for two consecutive days (J0, J1). And the following evaluations will be done:

* Nocturnal oxymetric + Epworth questionnaire + clinical questionnaire to detect sleep perturbations at home.
* Blood pressure + heart rate measure
* Ambulatory blood pressure monitoring on 24 hours
* Polysomnographic measurements during the J0-J1 night spend at the hospital.
* Questionnaire of sleep quality and of quality of life.
* Glycemic measurements on 24h (J0-J1).
* Measure of the baroreflex sensibility during the awake period at J1.
* Electrocardiogram
* Biological examinations (blood and urinary).

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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Biological examinations (blood and urinary).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male and female patients between 18 and 60 years of age
* Who have given their written consent to participate in this study
* Who are affiliated to the French social security system
* Are able to travel to Grenoble University Hospital
* Type I diabetes in reference to the 1997 criteria (American Diabetes Association) without any recent cetoacidosis or severe hypoglycaemia during the previous month and with a HbA1c \< 10% during the previous month.
* Normal blood pressure or essential hypertension light or moderate (SBP) at rest in the sitting position \>= 140 mmHg and \< 180 mmHg and/or PAD \>= 90 mmHg et \< 110 mmHg), with or without treatment.

Exclusion Criteria

* Non stabilised diabetes with at least one episode of acidoketosis decompensation or hypoglycemic coma during the previous month.
* Diabetic nephropathy patent stage 4 with a creatinine \> 150 mol / L and / or creatinine clearance \<50 ml / min
* Diabetic nephropathy in evolution
* Severe hypertension (SBP at rest in the sitting position \>= 180 mmHg and/or DBP \>= 110 mmHg)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No