Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity (NCT06699810) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
United States12 participantsStarted 2025-01-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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