Clinical Trial: Diabetic Ketoacidosis: Brain Morphology and Cognition

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Acute and Long-term Neuroanatomical and Cognitive Evaluation of Adult Patients With First and Recurrent Episodes of Diabetic Ketoacidosis

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 Summary:

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.


Sponsor: Emory University

Current Primary Outcome: Acute change in brain morphology [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Long-term change in brain morphology [ Time Frame: 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 [ Time Frame: Baseline (72 hours after DKA), 3 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 3 month assessment.
  • Change in neurocognitive assessment [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Emory University

Dates:
Date Received: May 11, 2015
Date Started: February 2015
Date Completion: December 2017
Last Updated: October 13, 2016
Last Verified: October 2016