Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
Sponsored by Emory University
About this study
The goal of this study is to quantify day-to-day changes in blood glucose during treatment towards remission in ketosis-prone diabetes (KPDM) and describe them using a mathematical model of KPDM pathogenesis and remission.
Approximately half of newly diagnosed obese African Americans presenting with diabetic ketoacidosis (DKA) have clinical, metabolic and immunologic features of type 2 diabetes (T2D), also known as ketosis-prone diabetes (KPDM). Unlike patients with type 1 diabetes, with intensive insulin treatment, approximately 70% of patients with KPDM exhibit improved pancreatic β-cell function and insulin sensitivity to allow discontinuation of insulin therapy (indicating near-normoglycemia remission based on fasting blood glucose (FBG) \< 130 mg/dl and HbA1c \< 7% off insulin therapy during follow-up\]). The clinical course of KPDM is variable, with the duration of remission ranging from 6 to 120 months. The origins of this variation in the ability to achieve remission and its duration are poorly under…
Where this study is enrolling (2)
- I'm interested
Emory University Hospital Midtown
Atlanta, Georgia
- I'm interested
Grady Health System
Atlanta, Georgia
Who can participate
Inclusion criteria
- ✓Provide informed consent
- ✓Have a BMI ≥ 28 kg/m2
- ✓Be of African American ancestry
- ✓Meet diagnostic criteria for DKA. Diagnostic criteria for DKA will include a plasma glucose \> 250 mg/dl, a venous pH \< 7.30, a serum bicarbonate \< 18 mmol/l, and serum ketones (beta-hydroxy butyrate) \> 1.5 mmol/L.
Exclusion criteria
- ✕Significant medical or surgical illness including but not limited to myocardial ischemia, congestive heart failure, chronic peripheral venous insufficiency, chronic renal insufficiency, liver insufficiency (serum transaminases 3 times the upper limit of normal) and acute or chronic infectious processes
- ✕Have recognized uncontrolled endocrine disorders such as hypercortisolism, acromegaly, or hyperthyroidism
- ✕Anemia (hemoglobin \< 12.5 g/dL for men, \<11.5 gm/dL for women), bleeding disorders, or abnormalities in coagulation studies
- ✕Pregnant
- ✕Diagnosis of diabetes \> 90 days before the presentation of DKA
- ✕Unable to give consent
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Trial data sourced from ClinicalTrials.gov.