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Search / Trial NCT06699810

Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity

Launched by EMORY UNIVERSITY · Nov 19, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Diabetic Ketoacidosis Type 2 Diabetes

ClinConnect Summary

This clinical trial is studying a specific type of diabetes called ketosis-prone diabetes (KPDM) to understand how daily changes in blood sugar levels can lead to remission, or improvement, of the condition. Researchers aim to develop a mathematical model that explains how KPDM develops and how it can be treated effectively. The trial is currently recruiting participants who are between 65 and 74 years old, of African American ancestry, and have a body mass index (BMI) of 28 or higher.

To be eligible, participants must also have experienced a serious condition called diabetic ketoacidosis (DKA), which is characterized by very high blood sugar levels and other specific health markers. However, individuals with certain serious health issues, uncontrolled hormone disorders, or recent diabetes diagnoses are not eligible to take part. Those who join the study can expect to closely monitor their blood sugar levels and contribute to important research that could help improve treatment options for this type of diabetes.

Gender

ALL

Eligibility 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

About Emory University

Emory University, a leading research institution located in Atlanta, Georgia, is dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Emory harnesses the expertise of its renowned faculty and state-of-the-art facilities to conduct cutting-edge research across various fields, including oncology, neurology, and infectious diseases. The university's commitment to ethical research practices and patient safety ensures that all clinical trials are designed to generate valuable data that can lead to significant therapeutic advancements. By fostering partnerships with local hospitals and community organizations, Emory strives to translate research findings into real-world applications, ultimately enhancing health outcomes for diverse populations.

Locations

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Patients applied

0 patients applied

Trial Officials

Priyathama Vellanki, MD, MS

Principal Investigator

Emory University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported