Clinical trial NCT02443415: Diabetic Ketoacidosis: Brain Morphology and Cognition
Official title: Acute and Long-term Neuroanatomical and Cognitive Evaluation of Adult Patients With First and Recurrent Episodes of Diabetic Ketoacidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Ketoacidosis
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with diabetic ketoacidosis (DKA) will be recruited from Emory University Hospital and Grady Memorial Hospital patients when DKA is treated. Diabetic subjects and age-matched controls will be recruited from physician referrals.

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute change in brain morphology
timeFrame: Baseline, 1 month
Secondary outcomes:
measure: Long-term change in brain morphology
timeFrame: Baseline, 4 months
measure: Change in neurocognitive assessment
timeFrame: Baseline (72 hours after DKA), 3 months
measure: Change in neurocognitive assessment
timeFrame: Baseline (72 hours after DKA), 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: