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

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ClinicalTrials.gov Identifier: NCT02443415
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, 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))

Condition or disease
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
Actual Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Acute and Long-term Neuroanatomical and Cognitive Evaluation of Adult Patients With First and Recurrent Episodes of Diabetic Ketoacidosis
Study Start Date : February 2015
Actual Primary Completion Date : October 25, 2016
Actual Study Completion Date : October 1, 2017

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443415


Locations
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University

Responsible Party: Guillermo Umpierrez, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02443415     History of Changes
Other Study ID Numbers: IRB00077046
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Ketosis
Acidosis
Diabetic Ketoacidosis
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases