This trial is active, not recruiting.

Condition diabetic ketoacidosis
Sponsor Emory University
Start date February 2015
End date September 2016
Trial size 45 participants
Trial identifier NCT02443415, IRB00077046


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Non-diabetic subjects
Diabetic subjects (recent(< 1 year) diagnosis of diabetes) without a history of diabetic ketoacidosis (DKA)
Diabetic subjects that just had their primary event of diabetic ketoacidosis (DKA)
Diabetic subjects who have had three or more diabetic ketoacidosis (DKA) episodes

Primary Outcomes

Acute change in brain morphology
time frame: Baseline, 1 month

Secondary Outcomes

Long-term change in brain morphology
time frame: Baseline, 4 months
Change in neurocognitive assessment
time frame: Baseline (72 hours after DKA), 3 months
Change in neurocognitive assessment
time frame: Baseline (72 hours after DKA), 6 months

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title Acute and Long-term Neuroanatomical and Cognitive Evaluation of Adult Patients With First and Recurrent Episodes of Diabetic Ketoacidosis
Principal investigator Guillermo Umpierrez, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Emory University.