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

NCT00805974 | Terminated

• 2 other identifiers: 05132005/0479
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

diapasom; sleep quality; type I diabete; blood pressure; plasma glucose; daytime and nighttime variations

Outcome Measures

Primary Outcomes (2)

• Polysomnographic measurements during the D0-D1 night spend at the hospital

  inclusion visit

• Ambulatory blood pressure monitoring on 24 hours

  inclusion visit

Secondary Outcomes (1)

• Glycemic measurements on 24h (D0-D1).

  inclusion visit

Interventions

Biological examinations (blood and urinary). BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Pr Mallion Jean-Michel: collaborator
• Pr BAGUET Jean-Philippe: collaborator
• Pr BENHAMOU Pierre-Yves: collaborator
• Pr LEVY Patrick: collaborator
• Dr MOURET Sandrine: collaborator
• Dr ORMEZZANO Olivier: collaborator
• Pr PEPIN Jean-Louis: collaborator
• Dr TAMISIER Renaud: collaborator

Study Sites (1)

University Hospital

Grenoble, France

Location

Related Publications (1)

• 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.

  PMID: 20950392 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Sleep Initiation and Maintenance Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• MALLION Jean-Michel, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: October 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 14, 2009

Record last verified: 2009-01

Locations

FR (1)