Diabetic Ketoacidosis: Brain Morphology and Cognition

NCT02443415 | Completed DMC

• 1 other identifier: IRB00077046
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

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))

Conditions

Diabetic Ketoacidosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Long-term change in brain morphology

  Baseline, 4 months

• Change in neurocognitive assessment

  Baseline (72 hours after DKA), 3 months

• Change in neurocognitive assessment

  Baseline (72 hours after DKA), 6 months

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 13, 2015
• Study Start: February 1, 2015
• Primary Completion: October 25, 2016
• Study Completion: October 1, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

US (2)