T1DMNCT04054934
Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes
An observational study of T1DM and Sleep Disorders, Circadian Rhythm, run by Assaf-Harofeh Medical Center.
Trial summary
Type 1 diabetes mellitus (T1DM), makes its appearance during childhood and youth, but management implications last till late adulthood. Its treatment includes the combination of multiple daily glucose measurements, insulin administration and balanced nutrition. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- T1DM, Sleep Disorders, Circadian Rhythm, ADHD
- What is being tested?
- Reversed Circadian Rhythm and Normal Circadian Rhythm
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patiets ages 12-18 years with type 1 diabetes mellitus and healthy controls same age and gender distribution
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Influence of Circadian Clock on Diurnal Dietary Intake, Glucose Variability, Time Spent in Range, and Neuro-cognitive Achievements Among Adolescents With and Without Type 1 Diabetes
Type 1 diabetes mellitus (T1DM), makes its appearance during childhood and youth, but management implications last till late adulthood. Its treatment includes the combination of multiple daily glucose measurements, insulin administration and balanced nutrition. The goals of therapy are to achieve glycemic control (HbA1c < 7.5%), and minimal glycemic excursions. Furthermore, recent studies imply that keeping HbA1c within target range is not sufficient to prevent complications, attributed mainly to blood glucose level fluctuating from high to low, associated with food intake and adolescents behavior. The current implication of glycemic control on the central nervous system (CNS) includes abnormal electrical brain activity, structural changes in brain's white and grey matter, and cognitive impairment. Still, little is known on the effect of sleep pattern, including circadian rhythm reversal ("biological clock) on asymptomatic glycemic excursions, and on CNS functions. There is no data regarding the association of the biologic clock on CNS functionality among adolescents, nonetheless among T1DM adolescents, for whom behavior and circadian rhythm alterations may have harmful effect. The investigators propose a cross-over designed study by examining adolescents with and without T1DM during 2 weeks of regular sleeping pattern (night sleep), and during 2 weeks of sleeping during the day as happens during summer vacation. The main objective of the proposed study is to offer proof of the clinical and metabolic relevance and cognitive effects of the reversal of the circadian clock in adolescents with and T1DM during summer vacations and weekends. Study is designed to demonstrate a difference among healthy and diabetics during reversed night/day circadian clocks in the time spent within target range of glucose, performance on neuro cognitive tasks, electrical brain activity, and hormonal profile.
- Conditions
- T1DM, Sleep Disorders, Circadian Rhythm, ADHD, Memory Impairment
- Being tested
- Reversed Circadian Rhythm, Normal Circadian Rhythm
- Keywords
- T1DM, Hypothalamus, CORTICAL BRAIN, Glucose variability, Biological clock, Pediatrics
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Attention Deficit Disorder with Hyperactivity, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reversed Circadian RhythmBehavioural
Revered day/ night sleep cycle
Normal Circadian RhythmBehavioural
Normal day/ night sleep cycle
| Study group | Role | What they receive |
|---|---|---|
| Normal Circardian rhythm | Regular night sleep, with at least 7 hours length of sleep. Receives: Behavioral: Normal Circadian Rhythm | |
| Reversed circadian rhythm | Night/day circadian clock is opposite, with at least 7 hours length of sleep Receives: Behavioral: Reversed Circadian Rhythm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose
Score of neurocognitive tests for executive function according to day/night sleeping pattern session
Measured: 2 years
Affects of reversal circadian clock on Glucose Variability parameters among both healthy and T1DM adolescents .
Time spent in range of glucose of 70-180 mg/dl according to day/night sleeping pattern
Measured: 2 years
Affects of reversal circadian clock on sleep quality among both healthy and T1DM adolescents (mainly T1DM), controlled for BMI-SDS, and mean HbA1c in T1D patients.
Quality of sleep according to PSQI, according to day/night sleeping pattern
Measured: 2 years
Secondary outcomes (6)
Melatonin profile according to night/day sleep cycle among healthy and among T1D patients
Differences in levels of melatonin in nmol/l between sessions and between health and T1D patients
Measured: 2 years
Temperature according to night/day sleep cycle among healthy and among T1D patients
Differences in peripheral body temperature (celzius) between sessions and between health and T1D patients
Measured: 2 years
EEG registration in accordance with the circadian curve and neurocognitive achievements
Power of high frequency amplitude between night/sleep sessions among T1D and healthy
Measured: 2 years
MRI structural changes
DT1-MRI trajectoris areas of supra-chiasmatic nuclei sleeping pattern session
Measured: 2 years
Hormonal profile according to night/day sleep cycle among healthy and among T1D patients
Differences in levels of cortisol in nmol/l between sessions and between health and T1D patients
Measured: 2 years
Metabolic parameters according to night/day sleep cycle among healthy and among T1D patients
Differences in blood pressure (mmHG) between sessions and between health and T1D patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study startJan 2022 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T1DMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Western University, Canada, Hadassah Medical Organization
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054934
- Sponsor's protocol ID
- 0291-18
- Status last verified
- May 2020
- First submitted
- 26 May 2019
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Circadian Clock on Diurnal Dietary Intake, Glucose Variability, Time Spent in Range, and Neuro-cognitive Achievements Among Adolescents With and Without Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04054934
- Acronym / sponsor ID
- 0291-18
- Conditions
- T1DM, Sleep Disorders, Circadian Rhythm, ADHD, Memory Impairment
- Keywords
- T1DM, Hypothalamus, CORTICAL BRAIN, Glucose variability, Biological clock, Pediatrics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Western University, Canada, Hadassah Medical Organization
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 1 diabetes mellitus (T1DM), makes its appearance during childhood and youth, but management implications last till late adulthood. Its treatment includes the combination of multiple daily glucose measurements, insulin administration and balanced nutrition. The goals of therapy are to achieve glycemic control (HbA1c < 7.5%), and minimal glycemic excursions. Furthermore, recent studies imply that keeping HbA1c within target range is not sufficient to prevent complications, attributed mainly to blood glucose level fluctuating from high to low, associated with food intake and adolescents behavior. The current implication of glycemic control on the central nervous system (CNS) includes abnormal electrical brain activity, structural changes in brain's white and grey matter, and cognitive impairment. Still, little is known on the effect of sleep pattern, including circadian rhythm reversal ("biological clock) on asymptomatic glycemic excursions, and on CNS functions. There is no data regarding the association of the biologic clock on CNS functionality among adolescents, nonetheless among T1DM adolescents, for whom behavior and circadian rhythm alterations may have harmful effect. The investigators propose a cross-over designed study by examining adolescents with and without T1DM during 2 weeks of regular sleeping pattern (night sleep), and during 2 weeks of sleeping during the day as happens during summer vacation. The main objective of the proposed study is to offer proof of the clinical and metabolic relevance and cognitive effects of the reversal of the circadian clock in adolescents with and T1DM during summer vacations and weekends. Study is designed to demonstrate a difference among healthy and diabetics during reversed night/day circadian clocks in the time spent within target range of glucose, performance on neuro cognitive tasks, electrical brain activity, and hormonal profile.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Circardian rhythm | – | Behavioral: Normal Circadian RhythmRegular night sleep, with at least 7 hours length of sleep. |
| Reversed circadian rhythm | – | Behavioral: Reversed Circadian RhythmNight/day circadian clock is opposite, with at least 7 hours length of sleep |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patiets ages 12-18 years with type 1 diabetes mellitus and healthy controls same age and gender distribution
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- significant renal or liver function abnormalities
- head injuries,
- epileptic episodes
- psychiatric medications
- lack of Hebrew abilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reversed Circadian RhythmRevered day/ night sleep cycle | Behavioural | Reversed circadian rhythm |
| Normal Circadian RhythmNormal day/ night sleep cycle | Behavioural | Normal Circardian rhythm |
Primary outcome
Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose
Time frame: 2 years
Score of neurocognitive tests for executive function according to day/night sleeping pattern session
Affects of reversal circadian clock on Glucose Variability parameters among both healthy and T1DM adolescents .
Time frame: 2 years
Time spent in range of glucose of 70-180 mg/dl according to day/night sleeping pattern
Affects of reversal circadian clock on sleep quality among both healthy and T1DM adolescents (mainly T1DM), controlled for BMI-SDS, and mean HbA1c in T1D patients.
Time frame: 2 years
Quality of sleep according to PSQI, according to day/night sleeping pattern
6 secondary outcomes
Melatonin profile according to night/day sleep cycle among healthy and among T1D patients
Time frame: 2 years
Temperature according to night/day sleep cycle among healthy and among T1D patients
Time frame: 2 years
EEG registration in accordance with the circadian curve and neurocognitive achievements
Time frame: 2 years
MRI structural changes
Time frame: 2 years
Hormonal profile according to night/day sleep cycle among healthy and among T1D patients
Time frame: 2 years
Metabolic parameters according to night/day sleep cycle among healthy and among T1D patients
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of T1DM and Sleep Disorders, Circadian Rhythm, run by Assaf-Harofeh Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianna Rachmiel, M.D (+972-537346636, rmarianna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affects of reversal circadian clock on neuro cognitive tasks performance among healthy and T1D patients, according to glucose (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.