Diabetic Ketoacidosis: Brain Morphology and Cognition

Completed

• Conditions: Diabetic Ketoacidosis

• Registration Number: NCT02443415
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-13
• Primary Completion: 2016-10-25
• Status Verified: 2017-10
• Study Completion: 2017-10-01
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute change in brain morphology	Baseline, 1 month	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.

Secondary Outcome Measures

Name	Time	Method
Long-term change in brain morphology	Baseline, 4 months	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 4 month MRI.
Change in neurocognitive assessment	Baseline (72 hours after DKA), 6 months	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 6 month assessment.

Trial Locations

Locations (2)

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Grady Health System; 🇺🇸 Atlanta, Georgia, United States