# Planning for a Cohort Study on Neurocognitive Complication of Type 1 Diabetes in Children

> **NIH NIH U34** · UNIVERSITY OF CALIFORNIA AT DAVIS · 2020 · $352,245

## Abstract

Project Summary. Children with type 1 diabetes (T1D) suffer from subtle cognitive impairments and structural
alterations in the brain. These impairments progress with age and may eventually lead to increased difficulty
managing the disease, resulting in worsening glycemic control, potentially life-threatening complications, and
reductions in quality of life. Causes of cognitive decline in T1D are not well understood. Episodes of
hypoglycemia, chronic hyperglycemia, glycemic variability and diabetic ketoacidosis (DKA) have all been
suggested to play roles. Increased understanding of factors linked to cognitive decline in T1D, and the
mechanisms responsible for these associations, is essential such that interventions to preserve cognition could
be proposed. Recent data suggest that neuroinflammation resulting from hyperglycemia and episodes of DKA
may be play a prominent role in causing cognitive decline. There is also evidence that modifiable factors such
as nutrition, exercise, and sleep quality might modulate effects of chronic neuroinflammation and influence
cognitive outcomes. In this project, we will engage in efforts to plan a comprehensive study of factors
associated with cognition in children with T1D. At the completion of the proposed planning project, we will be
prepared to conduct a longitudinal cohort study of children with newly diagnosed T1D. This study will
determine how glycemic control and DKA exposure predict altered brain structure and cognition and establish
whether markers of neuronal injury and inflammatory processes explain these longitudinal relations. Proposed
assessments will include T1D-related factors (glycemic control, glycemic variability, hypoglycemia, DKA), brain
structure and cognitive function (attention, memory and IQ). In addition, we will plan measurements of
inflammatory mediators and markers of neuroinflammation using blood assays (cytokine measurements,
exosome analyses, RNA microarrays), and evaluate factors that might modify inflammation such as diet
(nutrient content), sleep quality and exercise. To optimize the study design, we will utilize the expertise of a
multidisciplinary team to develop the study protocol, including experts in pediatric diabetes, cognitive
development, neural and systemic inflammation, MR imaging, nutrition, sleep medicine, and data science. The
team will work together to finalizing the protocol, work-flow and outcome measures, and identify the necessary
computational infrastructure and data analysis strategies. The team will also assess study feasibility (factors
affecting enrollment success and tolerance of the protocol) and determine necessary sample size by
evaluating variability in biochemical and imaging measures. Alternative approaches to increase participant
retention, such as remote (online) versus in person cognitive testing, will be explored. At the conclusion of this
planning project, we will have developed and optimized a protocol to explore factors associated with cog...

## Key facts

- **NIH application ID:** 10020976
- **Project number:** 5U34DK123894-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA AT DAVIS
- **Principal Investigator:** SIMONA GHETTI
- **Activity code:** U34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $352,245
- **Award type:** 5
- **Project period:** 2019-09-20 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10020976

## Citation

> US National Institutes of Health, RePORTER application 10020976, Planning for a Cohort Study on Neurocognitive Complication of Type 1 Diabetes in Children (5U34DK123894-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10020976. Licensed CC0.

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