Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
Recruiting · NCT06699810 · Interventional (participants receive a specific treatment) · Lead sponsor: Emory University
View the official record on ClinicalTrials.gov →Interventions studied
Continuous Glucose MonitoringInsulin
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Grady Health System - Atlanta, Georgia, United States
- Emory University Hospital Midtown - Atlanta, Georgia, United States