Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426413
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2007-01-22
Brief Title:
Ketosis Prone Diabetes in African-Americans
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Ketosis Prone Diabetes Mellitus in African-Americans Insulin Signaling Proteomics and Outcomes
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Over 50 of obese African-Americans AA presenting with newly diagnosed severe hyperglycemia andor unprovoked diabetic ketoacidosis DKA display clinical metabolic and immunogenetic features of type 2 diabetes Prior studies indicate that these patients a have markedly decreased insulin secretion and impaired insulin action at presentation b absent or low prevalence of beta-cell autoantibodies and c are able to discontinue aggressive insulin therapy in 70 of cases within 3 months of follow-up These patients have been referred to as having ketosis-prone type 2 diabetes KPDM Most patients with KPDM however experience a hyperglycemic relapse within a year of insulin discontinuation Consequently patients with KPDM are an ideal model to follow throughout their clinical course The specific aims of this proposal are to 1 identify clinical metabolic and immunogenetic markers that alone or in combination are predictive of short- and long-term near-normoglycemic remission and 2 determine whether pioglitazone or sitagliptin therapy will delay an insulin-deficient relapse once insulin is discontinued The Principal Investigator hypothesizes that measures of beta-cell function at presentation alone or in combination with measures of insulin sensitivity will correlate with the ability of a patient to achieve and remain in near-normoglycemic remission She also hypothesizes that intervention compared to placebo will preserve beta-cell function improve insulin sensitivity and prevent an insulin-deficient relapse This prospective cohort study with a RCT arm would better characterize the natural history of KPDM facilitate the direction of long-term therapy and likely decrease the recurrence of DKA which is associated with increased mortality and morbidity
Detailed Description:
More than half of obese African-Americans AA with newly diagnosed diabetes presenting with diabetic ketoacidosis DKA display clinical metabolic and immunogenetic features of type 2 diabetes during follow-up Prior studies by our group and other investigators indicate that at presentation these patients a have markedly decreased insulin secretion and impaired insulin action b have low prevalence of positive B-cell autoantibodies and c respond to aggressive diabetic management with significant improvement in B-cell function and insulin sensitivity sufficient to allow discontinuation of insulin therapy Upon discontinuation of insulin the period of near-normoglycemia remission defined as the ability to discontinue insulin injections for one week and remain in good metabolic control - fasting blood glucose 120 mgdl and A1c 7 may last for a few months to several years These patients are referred to as having atypical diabetes Flatbush diabetes or ketosis-prone type 2 diabetes KPDM Patients with KPDM are therefore an ideal model to follow throughout their clinical course in order to correlate their response to treatment with the mechanisms and markers of short- and long-term remission and determine the optimal therapeutic approach in order to prevent future glycemic decompensation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 897-2003 | OTHER | Other | None |
| GCRC 1703 | OTHER | None | None |