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Completed

NCT Number: NCT02443415

Diabetic Ketoacidosis: Brain Morphology and Cognition

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University School of Medicine, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Acronym: DKA-Cog

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 13, 2015
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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