RecruitingPhase 4NCT06699810
Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
Sponsor
Emory University
Enrollment
12 participants
Start Date
Jan 23, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria6
- 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
Interventions
DEVICEContinuous Glucose Monitoring
After insulin discontinuation participants continue wearing their CGMs, for a total of 3 months.
DRUGInsulin
Participants will receive standard-of-care insulin treatment. Insulin dosing will be adjusted based on CGM glucose readings.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06699810