Diabetic Ketoacidosis: Brain Morphology and Cognition

Emory University45 enrolled

Overview

The purpose of this study is to assess brain and memory changes in patients with uncontrolled diabetes (a condition called diabetic ketoacidosis (DKA))

Diabetic ketoacidosis (DKA) is a common and serious medical problem. Most cases occur when patients forget or stop insulin injections. Some patients require frequent admissions to the hospital with DKA after stopping insulin. Many patients do not know why they stop insulin therapy. The investigators will test if patients with one or more episodes of DKA have poor memory and brain changes that may lead to poor management. In this study, the investigators will perform memory testing and brain images in subjects with initial DKA episode and subjects with more than 3 episodes of DKA. The results will be compared to subjects with diabetes and no history of DKA and healthy (non-diabetic) subjects. Each subject with DKA will have an MRI and cognitive testing done shortly after hospital discharge, 1 month, and 3 months after hospital discharge. Diabetic subjects without DKA and healthy controls will only come in for a single baseline visit and have a MRI and cognitive testing done.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetic Ketoacidosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or type 2 diabetes with diabetic ketoacidosis (DKA) * Age 18-50 years * Newly diagnosed or history of noncompliance with insulin therapy as precipitating cause of DKA * No significant medical or surgical illness as precipitating cause of DKA Exclusion Criteria: * Significant medical/surgical illness as precipitating cause of DKA (i.e. myocardial infarction, major surgery) * Associated significant medical or surgical condition within 6 months history * History of hypoglycemia unawareness * History of seizures, ischemic stroke or hemorrhage, and severe head trauma * History of symptomatic stenosis of major intracranial vessels * Dementia (mini-mental state examination (MMSE) score (r ≤ 24) or inability to cooperate) * Liver or renal failure or transplant * Severe hypertension (systolic blood pressure (BP) \>160 mm Hg and/or diastolic BP \>100 mm Hg or subjects taking ≥ 2 antihypertensive medications) * Malignancy * Current recreational drug or alcohol abuse * Magnetic resonance imaging (MRI) exclusions: any metal and bio-implants not compatible with 3 Tesla MRI, claustrophobia

Locations (2)

Grady Health System

Atlanta, Georgia, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Acute change in brain morphology

Changes in brain morphology will include quantitative measurements of regional cortical volume as well as of hippocampal and thalamic volumes. Change is the difference from baseline MRI and 1 month MRI.

Time frame: Baseline, 1 month

Secondary Outcomes

Long-term change in brain morphology

Time frame: Baseline, 4 months

Change in neurocognitive assessment

Assessment will focus in composite domains: verbal memory, visual memory, working memory, prospective memory, executive function processing speed, and reaction time. Change is the difference from baseline assessment and 3 month assessment.

Time frame: Baseline (72 hours after DKA), 3 months

Change in neurocognitive assessment

Time frame: Baseline (72 hours after DKA), 6 months

Data from ClinicalTrials.gov

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