Effects of Pramlintide on Endogenous Production of Very-low-density-lipoprotein (VLDL)-Triglyceride and Glucose in the Post Prandial State in T2DM
|ClinicalTrials.gov Identifier: NCT00732147|
Recruitment Status : Withdrawn (Sponsor could not fund.)
First Posted : August 11, 2008
Last Update Posted : June 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Pramlintide acetate Drug: Placebo||Not Applicable|
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.
- To determine the effects of Pramlintide on reducing endogenous production of very-low-density-lipoprotein (VLDL)-triglycerides(TG) 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Effects of Pramlintide on Endogenous Production of VLDL-Triglyceride and Glucose in the Post Prandial State in Type 2 Diabetes Mellitus|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Placebo Comparator: 2
Type 2 diabetes patients will receive placebo with 3 meals in experimental period.
120 micrograms given subcutaneously before each meal x 3.
Type 2 Diabetes patient will receive Pramlintide with 3 meals in experimental period.
Drug: Pramlintide acetate
120 micrograms given subcutaneously before each meal X 3.
Other Name: Symlin
- Endogenous glucose production [ Time Frame: 18 hours ]
- Endogenous VLDL-Triglyceride production [ Time Frame: 18 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732147
|Principal Investigator:||Stephen N. Davis, MD||Vanderbilt University|