Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients (DIAPASOM2)
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Purpose
The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients.
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.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes |
Device: Actimeter + blood pressure monitoring |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients |
- HbA1c in % [ Time Frame: Day 0 or Day 3 ] [ Designated as safety issue: No ]
- Objective sleep duration in minutes [ Time Frame: Day 0 to Day 3 ] [ Designated as safety issue: No ]
- Blood pressure in cm Hg [ Time Frame: Day 0, 24 hours ] [ Designated as safety issue: No ]
- Quality of life assessed through questionnaire [ Time Frame: Day 0 to Day 3 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
A sample of serum will be retained in order to compare indicators of inflammation with sleep duration and diabetes complications
| Enrollment: | 79 |
| Study Start Date: | November 2009 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
-
Device: Actimeter + blood pressure monitoring
- Actiwatch-16, Mini-Mitter Inc, Bend,Oregon
- SPACELABS 90207
The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
This study will enroll type 1 diabetes patients who come for a consultation in Grenoble University Hospital.
Inclusion Criteria:
- Patient affiliated to Social Security
- 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:
- Underage patient, major patient under guardianship or protected by the Law
- 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
Contacts and Locations| France | |
| Service de Diabétologie du Pr Halimi, CHU | |
| Grenoble Cedex 9, France, 38043 | |
| Principal Investigator: | Pierre-Yves Benhamou, PhD | University Hospital, Grenoble |
More Information
No publications provided
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT01017965 History of Changes |
| Other Study ID Numbers: | 0917, 2009-A00816-51 |
| Study First Received: | November 20, 2009 |
| Last Updated: | October 4, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Grenoble:
|
Type 1 diabetes |
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 May 19, 2013