Status:
TERMINATED
Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Pr Mallion Jean-Michel
Pr BAGUET Jean-Philippe
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-60 years
Phase:
NA
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 (...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00805974
Start Date
October 1 2005
End Date
December 1 2007
Last Update
January 14 2009
Active Locations (1)
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1
University Hospital
Grenoble, France