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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetic Ketoacidosis

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 Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Health System
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Healthy Controls; Non-diabetic subjects
Diabetics without DKA; Diabetic subjects (recent(< 1 year) diagnosis of diabetes) without a history of diabetic ketoacidosis (DKA)
First episode of DKA; Diabetic subjects that just had their primary event of diabetic ketoacidosis (DKA)
Three or more DKA episodes; Diabetic subjects who have had three or more diabetic ketoacidosis (DKA) episodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute change in brain morphology	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.	Baseline, 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term change in brain morphology	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.	Baseline, 4 months
Change in neurocognitive assessment	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.	Baseline (72 hours after DKA), 3 months
Change in neurocognitive assessment	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.	Baseline (72 hours after DKA), 6 months

Collaborators and Investigators

• Sponsor: Emory University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 25, 2016
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: May 11, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Acid-Base Imbalance; Acidosis; Ketosis; Diabetic Ketoacidosis
• Other Study ID Numbers: IRB00077046