Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis
NCT03717896
Acid-Base Imbalance, Acidosis
Boston, Massachusetts, United States
View Trial DetailsNCT Number: NCT02443415
The purpose of this study is to assess brain and memory changes in patients with uncontrolled diabetes (a condition called diabetic ketoacidosis (DKA))
Looking for future studies?
Notify Me18 year–50 year
All sexes
Observational
Emory University School of Medicine, Atlanta, Georgia, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Emory University
Other
Acute and Long-term Neuroanatomical and Cognitive Evaluation of Adult Patients With First and Recurrent Episodes of Diabetic Ketoacidosis
Acronym: DKA-Cog
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.
Published trials that share one or more normalized conditions with this study.
NCT03717896
Acid-Base Imbalance, Acidosis
Boston, Massachusetts, United States
View Trial DetailsNCT07467616
Acid-Base Imbalance, Acidosis
Erbil, Kurdistan Region, Iraq
View Trial DetailsNCT07423559
Acid-Base Imbalance, Acidosis
Tanta, Egypt
View Trial DetailsNCT05402579
Acid-Base Imbalance, Acidosis
Toronto, Ontario, Canada
View Trial Details