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

This study has been terminated.
(difficulties for including diabetic patients)
Sponsor:
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
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00805974
First received: December 9, 2008
Last updated: January 13, 2009
Last verified: January 2009
  Purpose

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.

Condition Intervention
Type 1 Diabetes
Biological: Biological examinations (blood and urinary).

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Polysomnographic measurements during the D0-D1 night spend at the hospital [ Time Frame: inclusion visit ] [ Designated as safety issue: No ]
  • Ambulatory blood pressure monitoring on 24 hours [ Time Frame: inclusion visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic measurements on 24h (D0-D1). [ Time Frame: inclusion visit ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805974

Locations
France
University Hospital
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
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
  More Information

No publications provided by University Hospital, Grenoble

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr MALLION Jean-Michel, Professor, PhD,, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00805974     History of Changes
Other Study ID Numbers: 0513, 2005/0479
Study First Received: December 9, 2008
Last Updated: January 13, 2009
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Grenoble:
diapasom
sleep quality
type I diabete
blood pressure
plasma glucose
daytime and nighttime variations

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2014