Understanding and modeling diabetes remission in ketosis-prone patients
Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
This study is testing how daily blood sugar levels change in newly diagnosed obese African Americans with ketosis-prone diabetes to see if better understanding can help improve their treatment and chances of remission.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06699810 on ClinicalTrials.gov |
What this trial studies
This study aims to quantify daily blood glucose changes during treatment for ketosis-prone diabetes (KPDM) and to describe these changes using a mathematical model. It focuses on newly diagnosed obese African Americans who present with diabetic ketoacidosis (DKA) and explores the relationship between glucotoxicity and the ability to achieve remission. The study will utilize continuous glucose monitoring and insulin interventions to gather data on patient responses and remission duration. By understanding the mechanisms behind KPDM, the researchers hope to improve treatment strategies for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are obese African American individuals with a BMI of 28 kg/m2 or higher who meet the diagnostic criteria for diabetic ketoacidosis.
Not a fit: Patients with significant medical illnesses, uncontrolled endocrine disorders, or those who have been diagnosed with diabetes for more than 90 days prior to DKA presentation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and potential remission strategies for patients with ketosis-prone diabetes.
How similar studies have performed: While the approach of modeling glucotoxicity in diabetes is innovative, similar studies have shown promise in understanding diabetes remission, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 1 other locations
- Grady Health System — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Priyathama Vellanki, MD, MS — Emory University
- Study coordinator: Priyathama Vellanki, MD, MS
- Email: priyathama.vellanki@emory.edu
- Phone: (404) 778-1687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.