Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Polysomnographic measurements during the D0-D1 night spend at the hospital
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
Brief Summary
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.
Detailed 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).
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Polysomnographic measurements during the D0-D1 night spend at the hospital
Time Frame: inclusion visit
Ambulatory blood pressure monitoring on 24 hours
Time Frame: inclusion visit
Secondary Outcomes
- Glycemic measurements on 24h (D0-D1).(inclusion visit)