Diabetic Ketoacidosis: Brain Morphology and Cognition (DKA-Cog)

Emory University

Status

Completed

Conditions

Diabetic Ketoacidosis

Study type

Observational

Funder types

Other

Identifiers

NCT02443415

IRB00077046

Details and patient eligibility

About

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

Full 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.

Enrollment

45 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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