Understanding and modeling diabetes remission in ketosis-prone patients
Official title: Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
Run by Emory University · NCT06699810 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Status | Recruiting |
| Started | January 23, 2025 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT06699810 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the approach of modeling glucotoxicity in diabetes is innovative, similar studies have shown promise in understanding diabetes remission, suggesting potential for success.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Intravenous arginine to help treat diabetic ketoacidosis in people with type 2 diabetes
This study tests whether a single IV dose of arginine given early in DKA can safely boost your own insulin and help adults with ketone-prone type 2 diabetes recover faster.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.