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

Primary Purpose

Type 1 Diabetes

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological examinations (blood and urinary).
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Type 1 Diabetes focused on measuring diapasom, sleep quality, type I diabete, blood pressure, plasma glucose, daytime and nighttime variations

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital

Outcomes

Primary Outcome Measures

Polysomnographic measurements during the D0-D1 night spend at the hospital
Ambulatory blood pressure monitoring on 24 hours

Secondary Outcome Measures

Glycemic measurements on 24h (D0-D1).

Full Information

First Posted
December 9, 2008
Last Updated
January 13, 2009
Sponsor
University Hospital, Grenoble
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT00805974
Brief Title
Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I
Acronym
DIAPASOM
Official Title
Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
difficulties for including diabetic patients
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Grenoble
Collaborators
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
diapasom, sleep quality, type I diabete, blood pressure, plasma glucose, daytime and nighttime variations

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Biological examinations (blood and urinary).
Primary Outcome Measure Information:
Title
Polysomnographic measurements during the D0-D1 night spend at the hospital
Time Frame
inclusion visit
Title
Ambulatory blood pressure monitoring on 24 hours
Time Frame
inclusion visit
Secondary Outcome Measure Information:
Title
Glycemic measurements on 24h (D0-D1).
Time Frame
inclusion visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MALLION Jean-Michel, Pr
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Grenoble
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20950392
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.
Results Reference
derived

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

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