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

Grenoble Alpes University Hospital Center (CHU)

Status

Terminated

Conditions

Type 1 Diabetes

Treatments

Biological: Biological examinations (blood and urinary).

Study type

Interventional

Funder types

Other

Identifiers

NCT00805974

0513

2005/0479

Details and patient eligibility

About

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.

Full description

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).

Enrollment

23 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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)