Acute and Long-term Neuroanatomical and Cognitive Evaluation of Adult Patients With First and Recurrent Episodes of Diabetic Ketoacidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Acute change in brain morphology
研究概览
简要总结
The purpose of this study is to assess brain and memory changes in patients with uncontrolled diabetes (a condition called diabetic ketoacidosis (DKA))
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Acute change in brain morphology
时间窗: 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.
次要结局
- Long-term change in brain morphology(Baseline, 4 months)
- Change in neurocognitive assessment(Baseline (72 hours after DKA), 6 months)
研究者
Guillermo Umpierrez
Professor
Emory University