Ignite Creation Date:
2024-05-05 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00732147
Status:
WITHDRAWN
Last Update Posted:
2021-07-22
First Post:
2008-08-06
Brief Title:
Effects of Pramlintide on Endogenous Production of Very-low-density-lipoprotein VLDL-Triglyceride and Glucose in the Post Prandial State in T2DM
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Effects of Pramlintide on Endogenous Production of VLDL-Triglyceride and Glucose in the Post Prandial State in Type 2 Diabetes Mellitus
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor could not fund
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetes affects almost 21 million people in the United States In this study we will test a drug called PramlintideSymlin and see how it works to lower blood sugar and fat levels after a meal Lowering high sugar levels and fat levels after a meal is very important in the prevention of the problems that persons with type 2 diabetes often encounter Hypothesis is that Pramlintide will lower blood sugar and fat levels after a meal
Detailed Description:
A well recognized and troublesome feature of diabetes management is the exacerbated post prandial glucose elevations following a typical high fat meal To date the mechanisms driving this increased post prandial glycemia are unclear Pramlintide is believed to affect intermediary metabolism as well as nutrient absorption The relative contributions from altered absorption and metabolism to the observed post prandial reductions in plasma glucose and TG concentrations remain uncertain however Combinations of radioactive and stable isotope labeling techniques are able to quantify the relevant fluxes of glucose and lipids in vivo in humans and are therefore able to provide quantitative answers to these questions
Aims
1 To determine the effects of Pramlintide on reducing endogenous production of very-low-density-lipoprotein VLDL-triglyceridesTG following a high fat breakfast lunch and dinner in patients with type 2 diabetes mellitus T2DM A triple isotope approach will be used to determine rate of appearance of VLDL-triglycerides following breakfast lunch and dinner
2 To compare the relative roles of slowed glucose absorption and reduced endogenous glucose production glucagonstatic mechanism in the glucose-lowering effects of Pramlintide in the post prandial state in patients with T2DM
Aims
1 To determine the effects of Pramlintide on reducing endogenous production of very-low-density-lipoprotein VLDL-triglyceridesTG following a high fat breakfast lunch and dinner in patients with type 2 diabetes mellitus T2DM A triple isotope approach will be used to determine rate of appearance of VLDL-triglycerides following breakfast lunch and dinner
2 To compare the relative roles of slowed glucose absorption and reduced endogenous glucose production glucagonstatic mechanism in the glucose-lowering effects of Pramlintide in the post prandial state in patients with T2DM
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