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Cross-sectional, Case Control Study of Neurocognitive Performance During Hyperglycemia , and Brain Tissue Integrity in Youth With Type 1 Diabetes and in Healthy (T1DM)

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ClinicalTrials.gov Identifier: NCT02923323
Recruitment Status : Unknown
Verified October 2016 by Assaf Harofeh MC, Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Collaborators:
Bar-Ilan University, Israel
Hadassah Medical Organization
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Brief Summary:

Study population : 90 Participants. 60 with T1DM , and 30 healthy controls. T1DM patients will be recruited by research publication in diabetes mellitus forums.

Baseline visit: informed consent signing. Medical history data, vital signs, physical exam and neurocognitive testing. Capillary glucose prior to testing > 70 mg/dl.

Session 2 - combined simultaneous EEG , continuous glucose monitor system (CGMS) assessment, neurocognitive testing, and sleep quality assessment.

Participants will be hospitalized for 30 hours in the continuous-EEG unit at the Pediatric Neurology Department, Assaf-Harofeh Medical Center. Continuous simultaneous EEG and CGMS monitoring, and two separate sessions of neurocognitive assessments at glucose > 240 mg/dl and at glucose < 180 mg/dl, respectively.

Neurocognitive assessment will be performed after lunch on day 1, and after lunch on day 2. Day 1, regular insulin dose before lunch, and a cognitive assessment which will be performed with glucose level > 70 mg/dl and below 180 mg/dl.

On day 2, with no regular insulin dose before lunch and the same cognitive test will be performed with glucose level > 240 mg/dl During the 30 hours the participants will be connected to continuous EEG recording, sleep monitoring and CGMS. The study participants and research team will be blinded to the EEG and CGMS readings while recorded.

Participants will be able to convey their daily activities in their room. They will have their regular diet and regular daily activities.

Participants will measure at least 4 blood glucose measurements by prick tests, insulin management by multiple daily injections or pump therapy and meals.

Healthy participants will measure twice daily as required for CGMS calibration. The participants will stay connected to the CGMS for additional 4 days at their home setting for complete sleep quality assessment by sleep diary and actigraph.

The first night in hospital is to assess the association between actigraph and EEG and CGMS variability. The 4 nights at home are for assessment of CGMS, quality of life and actigraph readings.

Control group (healthy) will perform only one session of neurocognitive studies on day 1, after lunch with no insulin injection and will be discharged after 24 hours, with the CGMS and actigraph


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: MRI including DTI , EEG, CGMS Behavioral: Neurocognitive tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Cross-sectional, Case Control Study of Electrical Activity and Neurocognitive Performance During Hyperglycemia and Near Normoglycemia, and Brain Tissue Integrity in Children and Youth With Type 1 Diabetes and in Healthy Population
Study Start Date : March 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 T1DM aged 12-18 years.
T1DM patients. Receiving regularly insulin. Interventions: performance of continuous EEG , CGMS, MRI of brain with DTI , actigraph, neurocognitive testing
Device: MRI including DTI , EEG, CGMS
Will be connected to continuous simultaneous systems

Behavioral: Neurocognitive tests
Will perform multiple tests of neurocognitive functions after lunch

Active Comparator: Group 2 Healthy aged 12-18 years.
Healthy Interventions: performance of continuous EEG , CGMS, MRI of brain with DTI , actigraph, neurocognitive testing
Device: MRI including DTI , EEG, CGMS
Will be connected to continuous simultaneous systems

Behavioral: Neurocognitive tests
Will perform multiple tests of neurocognitive functions after lunch




Primary Outcome Measures :
  1. Association between interstitial glucose concentration and EEG power [ Time Frame: 2 years ]
    continuous monitoring of both EEG readings and glucose


Secondary Outcome Measures :
  1. Association between interstitial glucose concentration and neurocognitive functions [ Time Frame: 2 years ]
    Association between glucose concentration in mg/dl and scoring on tests. The neurocognitive tests have numerical scoring. Those scores will be assessed according to glucose levels in the T1D group and health group in separate and between groups.


Other Outcome Measures:
  1. association between quality of sleep and glycemic control [ Time Frame: 2 years ]
    Quality of sleep will be assessed according to actigraph and correlated with HbA1c levels , and compared between groups

  2. DTI assessment of brain MRI according to HbA1c [ Time Frame: 2 years ]
    Brain DTI parameters will be compared between healthy and T1DM groups



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Families living in areas with high access to medical care.
  • Age:12-18 years old having diagnosed with T1DM for longer than 2 years.

Exclusion Criteria:

  • Head injuries
  • Epileptic episodes
  • Psychiatric medications
  • Lack of Hebrew abilities
  • Disagreement to keep with all study requests
  • History of more than one episode of severe hypoglycemic event in the past including loss of consciousness or more than one episode of diabetic ketoacidosis.
  • Patients with significant renal or liver function abnormalities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923323


Contacts
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Contact: Marianna Rachmiel, M.D 053-734-6636 ext +972 mariannar@asaf.health.gov.il

Locations
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Israel
Assaf Haroffeh Medical center Recruiting
Zerifin, Israel, 70300
Contact: Marianna Rachmiel, MD    972-8-9542007    rmarianna@gmail.com   
Sub-Investigator: Renana Gelernter, Md         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Bar-Ilan University, Israel
Hadassah Medical Organization
Investigators
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Principal Investigator: Marianna Rachmiel, M.D Assaf-Harofeh Medical Center

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Responsible Party: Assaf Harofeh MC, Dr. Marianna Rachmiel, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02923323    
Other Study ID Numbers: 97/14
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assaf Harofeh MC, Assaf-Harofeh Medical Center:
Neurocognitive Function
MRI
Diffusion Tensor Imaging (DTI)
Sleep
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases