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Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity Phase 4 12

Recruiting
Clinical Trial NCT06699810 is designed to study Basic Science for Ketosis Prone Diabetes. It is a Phase 4 interventional study that is recruiting, having started on 23 January 2025, with plans to enroll 12 participants. Led by Emory University, it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 27 January 2025.
Brief 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.
Detailed Description
Approximately half of newly diagnosed obese African Americans presenting with diabetic ketoacidosis (DKA) have clinical, metabolic and immunologic features of type 2 diabetes (T2D), also known as ketosis-prone diabetes (KPDM). Unlike patients with type 1 diabetes, with intensive insulin treatment, approximately 70% of patients with KPDM exhibit improved pancreatic β-cell function and insulin sensitivity to allow disc...Show More
Official Title

Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity

Conditions
Ketosis Prone Diabetes
Other Study IDs
  • STUDY00008366
NCT ID Number
NCT06699810
Start Date (Actual)
2025-01-23
Last Update Posted
2025-01-27
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
12
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
diabetic ketoacidosis
type 2 diabetes
Primary Purpose
Basic Science
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalContinuous Glucose Monitoring with Adjusted Insulin Doses
Patients with ketosis-prone diabetes will wear a continuous glucose monitor (CGM) from the time of hospital discharge until insulin discontinuation. Insulin doses will be adjusted based on CGM glucose readings.
Continuous Glucose Monitoring
After insulin discontinuation participants continue wearing their CGMs, for a total of 3 months.
Insulin
Participants will receive standard-of-care insulin treatment. Insulin dosing will be adjusted based on CGM glucose readings.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Quantify Changes in Blood Glucose
The day-to-day changes in blood glucose in KPDM will be quantified using CGMs.
Up to 3 months
Development of Mathematical Models
The study team will adapt and develop mathematical models to describe the course of KPDM remission in each individual patient, i.e. the entire range of variation within the group of 12 participants.
Up to 3 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Correlation of Fit With Model Parameters and Duration of Remission
The study team will validate mathematical models to predict duration of remission.
Up to 3 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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
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Study Responsible Party
Priyathama Vellanki, Principal Investigator, Associate Professor, Emory University
Study Central Contact
Contact: Priyathama Vellanki, MD, MS, (404) 778-1687, [email protected]
2 Study Locations in 1 Countries

Georgia

Grady Health System, Atlanta, Georgia, 30303, United States
Recruiting
Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States
Recruiting