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

Sponsors and Collaborators:	University Hospital, Grenoble Pr Mallion Jean-Michel Pr BAGUET Jean-Philippe Pr BENHAMOU Pierre-Yves Pr LEVY Patrick Dr MOURET Sandrine Dr ORMEZZANO Olivier Pr PEPIN Jean-Louis Dr TAMISIER Renaud
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00805974

Purpose

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.

Condition	Intervention
Type 1 Diabetes	Biological: Biological examinations (blood and urinary).

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Open Label, Single Group Assignment
Official Title:	Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

Polysomnographic measurements during the D0-D1 night spend at the hospital [ Time Frame: inclusion visit ] [ Designated as safety issue: No ]
Ambulatory blood pressure monitoring on 24 hours [ Time Frame: inclusion visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glycemic measurements on 24h (D0-D1). [ Time Frame: inclusion visit ] [ Designated as safety issue: No ]

Enrollment:	23
Study Start Date:	October 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805974

Locations

France
University Hospital
Grenoble, France

Sponsors and Collaborators

University Hospital, Grenoble

Pr Mallion Jean-Michel

Pr BAGUET Jean-Philippe

Pr BENHAMOU Pierre-Yves

Pr LEVY Patrick

Dr MOURET Sandrine

Dr ORMEZZANO Olivier

Pr PEPIN Jean-Louis

Dr TAMISIER Renaud

Investigators

Principal Investigator:

MALLION Jean-Michel, Pr

University Hospital, Grenoble

More Information

Responsible Party:	University Hospital, Grenoble ( Pr MALLION Jean-Michel, Professor, PhD, )
Study ID Numbers:	0513, 2005/0479
Study First Received:	December 9, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00805974
Health Authority:	France: Direction Générale de la Santé

Keywords provided by University Hospital, Grenoble:

diapasom
sleep quality
type I diabete

blood pressure
plasma glucose
daytime and nighttime variations

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009