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

January 13, 2009 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Polysomnographic measurements during the D0-D1 night spend at the hospital
Time Frame: inclusion visit
inclusion visit
Ambulatory blood pressure monitoring on 24 hours
Time Frame: inclusion visit
inclusion visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Glycemic measurements on 24h (D0-D1).
Time Frame: inclusion visit
inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Principal Investigator: MALLION Jean-Michel, Pr, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 9, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (Estimate)

December 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 14, 2009

Last Update Submitted That Met QC Criteria

January 13, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0513
  • 2005/0479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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