Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity

Trial ID: NCT06699810

Interventional - Phase 4 - Recruiting

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.

Conditions

• Ketosis Prone Diabetes

Interventions

• Continuous Glucose Monitoring
• Insulin

Eligibility

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

Sponsor

Emory University

Source: ClinicalTrials.gov

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