RightFit
RecruitingPhase 4

Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "It has been observed that a 20-hour infusion of glucose reduces pancreatic beta (β)-cell function in a KPDM patient, and ketotic relapse is often preceded by hyperglycemia."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks daily changes in blood sugar during treatment for ketosis-prone diabetes, a type of diabetes that can cause acids called ketones to build up in the blood. It uses a math model to study how the disease develops and improves. It is for people of African American ancestry who meet the study’s body size and blood test rules.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Understand the study and agree to take part.
  • Have a body mass index (BMI) of at least 28. BMI measures body size using height and weight.
  • Be of African American ancestry.
  • Have diabetic ketoacidosis (DKA), a dangerous buildup of acids in the blood, with all these test results: blood sugar above 250 mg/dL, vein blood pH below 7.30, bicarbonate below 18 mmol/L, and blood ketones (beta-hydroxybutyrate) above 1.5 mmol/L.

Who can't join

  • Have a serious medical or surgical illness, such as poor blood flow to the heart, heart failure, long-term problems with leg veins or kidneys, liver problems, or a short-term or long-term infection. The liver test cutoff is liver enzymes at 3 times the upper normal limit.
  • Have a known hormone disorder that is not controlled, such as too much cortisol, growth hormone, or thyroid hormone.
  • Have anemia (low red blood cells), with hemoglobin below 12.5 g/dL for men or 11.5 g/dL for women; a bleeding disorder; or abnormal blood-clotting tests.
  • Be pregnant.
  • Have been diagnosed with diabetes more than 90 days before DKA occurred.
  • Be unable to understand the study and agree to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

GA