Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of Arizona |
---|---|
Information provided by: | University of Arizona |
ClinicalTrials.gov Identifier: | NCT00848822 |
The purpose of this project is to look at how sleep affects glucose values in children with Type 1 Diabetes Mellitus. It will also evaluate if glucose is affected by times of day due to the body's own internal rhythm also known as the circadian rhythm.
Condition |
---|
Type 1 Diabetes Mellitus Sleep |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus |
Estimated Enrollment: | 50 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Diabetes Mellitus (DM) is one of the most prevalent chronic pediatric diseases, affecting 2.80 cases per 1000 youth between the ages of 10 and 19. Since the crux of diabetes management is glucose regulation, any further challenges such as stress and/or poor sleep may make glucose regulation even more difficult. Mounting evidence supports the association between inadequate sleep and obesity as well as metabolic syndrome. Despite emerging findings supporting that total sleep time (TST) may contribute to the risk of obesity and/or metabolic complications, less research has been focused on Type 1 Diabetes Mellitus (T1DM) and on other sleep parameters.
Participants will have a Continuous Glucose Monitor (CGM) and actigraph placed which they will wear for 5 days.
At the end of the 5 days, they will return the glucose meter, CGM, and actigraph to a clinic staff or research team member to download their data. They will provide us with a glucose log that contains the glucose levels obtained from a fingerstick capillary glucose meter. In this log, participants will also record their activities, meals, and insulin administered. They will also provide us with a sleep diary. In addition, participants will have the option for the child to undergo polysomnography (sleep study) for one night in their home or two nights in the sleep lab.
Ages Eligible for Study: | 10 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Pariticipants will be recruited from the Angel Clinic for Children with Diabetes and Endocrine Disorders which is part of University Medical Center in Tucson, Arizona
Inclusion Criteria:
Exclusion Criteria:
Contact: Priti G Patel, M.D. | 520-626-6077 | pgpatel@email.arizona.edu |
Contact: Michelle M Perfect, PhD | 520-626-1128 | kidsleep@email.arizona.edu |
United States, Arizona | |
Steele Research Memorial Foundation, Angel Clinic for Children with Diabetes and Endocrine Disorders | Recruiting |
Tucson, Arizona, United States, 85724 | |
Contact: Priti G Patel, M.D. 520-626-6077 pgpatel@email.arizona.edu | |
Contact: Michelle Perfect, PhD 520-626-1128 kidssleep@email.arizona.edu |
Principal Investigator: | Priti G Patel, M.D. | University of Arizona |
Principal Investigator: | Michelle Perfect, PhD | Univeristy of Arizona |
Responsible Party: | University of Arizona ( Priti Patel, M.D. ) |
Study ID Numbers: | 08-1108-01 |
Study First Received: | February 18, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00848822 History of Changes |
Health Authority: | United States: Institutional Review Board |
Pediatrics Sleep Glucose regluation Type 1 Diabetes Mellitus |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |