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Diabetic Ketoacidosis: Brain Morphology and Cognition

NCT ID: NCT02443415

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-10-01

Brief Summary

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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

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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.

Conditions

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Diabetic Ketoacidosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Controls

Non-diabetic subjects

No interventions assigned to this group

Diabetics without DKA

Diabetic subjects (recent(\< 1 year) diagnosis of diabetes) without a history of diabetic ketoacidosis (DKA)

No interventions assigned to this group

First episode of DKA

Diabetic subjects that just had their primary event of diabetic ketoacidosis (DKA)

No interventions assigned to this group

Three or more DKA episodes

Diabetic subjects who have had three or more diabetic ketoacidosis (DKA) episodes

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Guillermo Umpierrez

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Grady Health System

Atlanta, Georgia, United States

Site Status

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00077046

Identifier Type: -

Identifier Source: org_study_id