Diabetic Ketoacidosis: Brain Morphology and Cognition

Diabetic Ketoacidosis Clinical Trial

— DKA-Cog  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443415
• Other study ID #: IRB00077046
• Status: Completed
• Phase: N/A
• First received: May 11, 2015
• Last updated: October 23, 2017
• Start date: February 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 1, 2017
• Est. primary completion date: October 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Diabetic Ketoacidosis
• Ketosis

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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