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

Not Applicable

Terminated

• Conditions: Type 1 Diabetes

• Registration Number: NCT00805974
• Lead Sponsor: University Hospital, Grenoble

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).

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-13
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Polysomnographic measurements during the D0-D1 night spend at the hospital	inclusion visit
Ambulatory blood pressure monitoring on 24 hours	inclusion visit

Secondary Outcome Measures

Name	Time	Method
Glycemic measurements on 24h (D0-D1).	inclusion visit

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Grenoble, France