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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00805974
Acronym
DIAPASOM
Enrollment
23
Registered
2008-12-10
Start date
2005-10-31
Completion date
2007-12-31
Last updated
2009-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

diapasom, sleep quality, type I diabete, blood pressure, plasma glucose, daytime and nighttime variations

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).

Interventions

BIOLOGICALBiological examinations (blood and urinary).

Sponsors

Pr Mallion Jean-Michel
CollaboratorUNKNOWN
Pr BAGUET Jean-Philippe
CollaboratorUNKNOWN
Pr BENHAMOU Pierre-Yves
CollaboratorUNKNOWN
Pr LEVY Patrick
CollaboratorUNKNOWN
Dr MOURET Sandrine
CollaboratorUNKNOWN
Dr ORMEZZANO Olivier
CollaboratorUNKNOWN
Pr PEPIN Jean-Louis
CollaboratorUNKNOWN
Dr TAMISIER Renaud
CollaboratorUNKNOWN
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Polysomnographic measurements during the D0-D1 night spend at the hospitalinclusion visit
Ambulatory blood pressure monitoring on 24 hoursinclusion visit

Secondary

MeasureTime frame
Glycemic measurements on 24h (D0-D1).inclusion visit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026