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Recruiting Phase 4 NCT06699810

Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity

Trial Parameters

Condition Ketosis Prone Diabetes
Sponsor Emory University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 12
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-01-23
Completion 2025-12
Interventions
Continuous Glucose MonitoringInsulin

Brief Summary

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.

Eligibility Criteria

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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