Clinical trial NCT00805974: Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I
Official title: Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: diapasom
sleep quality
type I diabete
blood pressure
plasma glucose
daytime and nighttime variations
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Pr Mallion Jean-Michel
name: Pr BAGUET Jean-Philippe
name: Pr BENHAMOU Pierre-Yves
name: Pr LEVY Patrick
name: Dr MOURET Sandrine
name: Dr ORMEZZANO Olivier
name: Pr PEPIN Jean-Louis
name: Dr TAMISIER Renaud
First posted: 2008-12-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

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)

Primary outcomes:
measure: Polysomnographic measurements during the D0-D1 night spend at the hospital
timeFrame: inclusion visit
measure: Ambulatory blood pressure monitoring on 24 hours
timeFrame: inclusion visit
Secondary outcomes:
measure: Glycemic measurements on 24h (D0-D1).
timeFrame: inclusion visit
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: MALLION Jean-Michel, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borel AL, Benhamou PY, Baguet JP, Halimi S, Levy P, Mallion JM, Pepin JL. High prevalence of obstructive sleep apnoea syndrome in a Type 1 diabetic adult population: a pilot study. Diabet Med. 2010 Nov;27(11):1328-9. doi: 10.1111/j.1464-5491.2010.03096.x. No abstract available.