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

Type 1 Diabetes Clinical Trial

— DIAPASOM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00805974
• Other study ID #: 0513
• Secondary ID: 2005/0479
• Status: Terminated
• Phase: N/A
• First received: December 9, 2008
• Last updated: January 13, 2009
• Start date: October 2005
• Est. completion date: December 2007

Study information

• Verified date: January 2009
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Biological:
• Biological examinations (blood and urinary).

Locations

Country	Name	City	State
France	University Hospital	Grenoble

Sponsors (9)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnographic measurements during the D0-D1 night spend at the hospital		inclusion visit	No
Primary	Ambulatory blood pressure monitoring on 24 hours		inclusion visit	No
Secondary	Glycemic measurements on 24h (D0-D1).		inclusion visit	No