Neurocognitive Performance During Hyperglycemia , and Brain Tissue Integrity in Youth With Type 1 Diabetes and in Healthy

NCT02923323 | Unknown DMC

• 1 other identifier: 97/14
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 1

Keywords

Neurocognitive Function; MRI; Diffusion Tensor Imaging (DTI); Sleep

Outcome Measures

Primary Outcomes (1)

• Association between interstitial glucose concentration and EEG power

  continuous monitoring of both EEG readings and glucose

  2 years

Secondary Outcomes (1)

• Association between interstitial glucose concentration and neurocognitive functions

  2 years

Other Outcomes (2)

• association between quality of sleep and glycemic control

  2 years

• DTI assessment of brain MRI according to HbA1c

  2 years

Study Arms (2)

Group 1 T1DM aged 12-18 years.

EXPERIMENTAL

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; Behavioral: Neurocognitive tests

Group 2 Healthy aged 12-18 years.

ACTIVE COMPARATOR

Healthy Interventions: performance of continuous EEG , CGMS, MRI of brain with DTI , actigraph, neurocognitive testing

Device: MRI including DTI , EEG, CGMS; Behavioral: Neurocognitive tests

Interventions

MRI including DTI , EEG, CGMS DEVICE

Will be connected to continuous simultaneous systems

Group 1 T1DM aged 12-18 years.; Group 2 Healthy aged 12-18 years.

Neurocognitive tests BEHAVIORAL

Will perform multiple tests of neurocognitive functions after lunch

Group 1 T1DM aged 12-18 years.; Group 2 Healthy aged 12-18 years.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Bar-Ilan University, Israel: collaborator
• Hadassah Medical Organization: collaborator

Study Sites (1)

Assaf Haroffeh Medical center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Electroencephalography; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Marianna Rachmiel, M.D

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Marianna Rachmiel

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: October 4, 2016
• Study Start: March 1, 2016
• Primary Completion: October 15, 2019
• Study Completion: May 15, 2025
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)