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| Sponsored by: |
Emory University |
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00426413 |
Purpose
Diabetes mellitus is a major risk factor for cardiovascular and stroke and up to a third of all hospital admissions are associated with diabetes. The disease is strongly linked to obesity, particularly in African-American (AA) patients with new-onset diabetes. More than 50% of recently diagnosed AA patients with very high blood glucose (sugar) levels are obese. Although these patients have diminished action of insulin, the majority of patients significantly improve after ~10 weeks of insulin therapy and can discontinue insulin injections. The mechanism of this recovery is unknown but preliminary data suggest that the impaired body's response to insulin results from altered insulin release from the pancreas, the organ that produces insulin in the body, and altered insulin action inside the cells, in a molecule called Akt. In this study we will assess the ability of the pancreas to release insulin by performing a glucagon stimulation test. Glucagon is a potent stimulator for insulin release from the pancreas. We will also obtain muscle biopsies in the thigh muscles (small amount of muscle will be obtained through a special needle) in obese AA patients admitted with high blood sugar. We will analyze the muscle tissue for abnormalities in the molecule called Akt. Following the biopsy, patients will undergo a study using glucose and insulin that will provide a measure of the patient's sensitivity to insulin. Biopsies will be performed under local anesthesia and will be obtained shortly after admission and at 12 weeks of diabetes therapy or sooner if insulin can be discontinued before 12 weeks. The glucagon stimulation test will be performed every 6 months for one year to assess the ability of the pancreas to make insulin. These studies will allow understanding of mechanisms that lead to severe hyperglycemia (high blood sugar).
| Condition |
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Ketosis Prone Diabetes Diabetic Ketoacidosis Severe Hyperglycemia |
| MedlinePlus related topics: | Diabetes Diabetes Type 1 Obesity |
| ChemIDplus related topics: | Insulin |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Ketosis Prone Diabetes Mellitus in African-Americans: Insulin Signaling, Proteomics, and Outcomes |
| Estimated Enrollment: | 44 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | December 2006 |
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 mg/dl 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 mechanism(s) and markers of short- and long-term remission and determine the optimal therapeutic approach in order to prevent future glycemic decompensation.
Eligibility
| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Diagnostic criteria for DKA will include:
Obese hyperglycemic patients will have:
Exclusion Criteria:
Contacts and Locations| Contact: Dawn D Smiley, MD | 404-778-1664 | dsmiley@emory.edu |
| Contact: Guillermo E Umpierrez, MD | 404-778-1665 | geumpie@emory.edu |
| United States, Georgia | |||||
| Grady Memorial Hospital | Recruiting | ||||
| Atlanta, Georgia, United States, 30303 | |||||
| Emory University |
| Principal Investigator: | Dawn D Smiley, MD | Emory University |
More Information
| Responsible Party: | Emory University School of Medicine ( Dawn smiley, MD ) |
| Study ID Numbers: | 897-2003, GCRC 1703, K12-RR017643 |
| First Received: | January 22, 2007 |
| Last Updated: | March 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00426413 |
| Health Authority: | United States: Institutional Review Board |
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