Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients
NCT ID: NCT01017965
Last Updated: 2012-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
79 participants
OBSERVATIONAL
2009-11-30
2012-04-30
Brief Summary
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This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life.
Last, it will investigate the influence of objective physical activity duration on blood glucose control, blood pressure and quality of life.
Detailed Description
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This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life.
Last, it will investigate the influence of objective physical activity duration on blood glucose control, blood pressure and quality of life.
This study will enrol ambulatory patients only. On day 0, patients receive an actimeter and an ambulatory blood pressure monitoring device. The actimeter measures activity and sleep duration. The patient keeps the actimeter for 3 consecutive days and the blood pressure monitoring device for 24 hours. A blood sample is also collected.
Patients will be divided into 2 groups, based on objective sleep duration: 'short-sleepers' and 'long-sleepers'. The threshold will be the median of the total population. HbA1c will be compared between the 2 groups with a Student test or a Mann-Whitney test, depending on the normality of distribution.
A model of multiple linear regression will be created. HbA1c will be entered as dependant variable and objective sleep duration as independent variable
Patients will be divided into 2 groups, based on objective activity duration: 'low-activity' and 'high-activity'. The threshold will be the median of the total population. HbA1c, blood pressure, quality of life, biological results and general characteristics will be compared between the 2 groups with a Student test or a Mann-Whitney test, depending on the normality of distribution. Qualitative variables will be studied with a chi-square test.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Actimeter + blood pressure monitoring
Patients will receive an actimeter that they will wear for 3 days and an ambulatory blood pressure monitoring device that they will keep for 24 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written consent to participate to the study
* Ambulatory medical follow-up
* Patient with type 1 diabetes, defined by the criteria of the American Diabetes Association in 1997, stable (no ketoacidosis episode or hypoglycaemia with loss of consciousness requiring the intervention of a third person, during the previous month)
Exclusion Criteria
* Pregnant, parturient or breastfeeding woman
* Person with no freedom (prisoner), person hospitalized without consent and not protected by the Law
* Non-stabilized diabetes with at least one ketoacidosis episode or hypoglycaemia with loss of consciousness requiring the intervention of a third person, during the previous month.
* Bedridden person or person with mobility impairment.
* Patient already hospitalized at enrolment time
* Patient whose physical or psychological health could interfere with obtention of informed consent and compliance to the protocol (especially answers to the questionnaires)
* Terminally-ill patient
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Pierre-Yves Benhamou, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Service de Diabétologie du Pr Halimi, CHU
Grenoble, , France
Countries
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References
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Borel AL, Pepin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28.
Other Identifiers
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2009-A00816-51
Identifier Type: REGISTRY
Identifier Source: secondary_id
0917
Identifier Type: -
Identifier Source: org_study_id