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Search / Trial NCT04054934

Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes

Launched by ASSAF-HAROFEH MEDICAL CENTER · Aug 10, 2019

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

T1 Dm Hypothalamus Cortical Brain Glucose Variability Biological Clock Pediatrics

ClinConnect Summary

This clinical trial is looking at how changes in sleep patterns, specifically the body’s internal clock or "circadian rhythm," affect teenagers with Type 1 diabetes (T1DM) compared to those without diabetes. Researchers want to understand how sleeping at night versus during the day might impact blood sugar control, brain activity, and thinking abilities in adolescents. The study will involve healthy teens and those with T1DM over a period of four weeks, where they will spend two weeks following a regular sleep schedule and two weeks sleeping during the day, similar to summer vacation.

To participate in this study, teens aged 12 to 18 who have been diagnosed with T1DM for over a year and speak fluent Hebrew may be eligible. However, some teens will not be able to join if they have serious kidney or liver issues, a history of head injuries, or have been prescribed certain psychiatric medications. Participants can expect to take part in tests that measure their glucose levels, brain activity, and cognitive performance during both sleep patterns. This research aims to shed light on how sleep and circadian rhythms might affect health and cognitive function in adolescents, especially those managing diabetes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Families living in areas with high access to medical care.
  • Age: 12-18 years old
  • T1D diagnosis for longer than 1 year
  • speaking fluent Hebrew
  • Exclusion Criteria:
  • significant renal or liver function abnormalities
  • head injuries,
  • epileptic episodes
  • psychiatric medications
  • lack of Hebrew abilities
  • disagreement to comply with all the study requests
  • history of more than one episode of a severe hypoglycemic event in the past, including loss of consciousness or more than one episode of diabetic ketoacidosis.

About Assaf Harofeh Medical Center

Assaf-Harofeh Medical Center is a prominent healthcare institution located in Israel, renowned for its commitment to advancing medical research and improving patient care. As a key sponsor of clinical trials, the center focuses on a diverse range of therapeutic areas, leveraging its state-of-the-art facilities and interdisciplinary expertise to facilitate innovative studies. With a dedicated team of experienced researchers and clinicians, Assaf-Harofeh Medical Center is dedicated to fostering scientific breakthroughs that enhance treatment outcomes and contribute to the global medical community.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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