Status:
COMPLETED
Mechanism Underlying Beta-cell Failure in Obese African Americans With History of Hyperglycemic Crises
Lead Sponsor:
Emory University
Collaborating Sponsors:
American Diabetes Association
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Obesity is common in African American (AA) patients with newly diagnosed diabetes who present with diabetic ketoacidosis (DKA). Despite the presentation with severe symptoms of insulinopenia and ketoa...
Detailed Description
Obese AA patients with a history of DKA who later experience near-normoglycemia remission represent an ideal population in which to define the sequence of events that lead to b-cell dysfunction in typ...
Eligibility Criteria
Inclusion
- Obese African American subjects (body mass index (BMI) equal or greater than 30)
- Age 18-65
- Patients with a history of diabetic ketoacidosis as defined by the American Diabetes Association (ADA) criteria
- Patients admitted with hyperglycemia but without ketoacidosis (blood glucose greater than 400ml/dl without evidence of ketosis/ketones
- Obese nondiabetic controls (BMI \>30; ruled out for diabetes with a 75g oral glucose tolerance test)
Exclusion
- Patients with positive autoimmune markers (islet cell or glutamic acid decarboxylase (GAD) autoantibodies)
- Patients with significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes
- Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism
- Patients with bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies
- Patients with fasting hyperglycemia (blood glucose \> 120 mg/dl) after discontinuation of insulin therapy
- Pregnancy
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00753142
Start Date
March 1 2004
End Date
December 1 2009
Last Update
October 12 2018
Active Locations (1)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303