DRUG
Pramlintide acetate
120 micrograms given subcutaneously before each meal X 3.
Effects of Pramlintide on Endogenous Production of Very-low-density-lipoprotein (VLDL)-Triglyceride and Glucose in the Post Prandial State in T2DM
Status
Withdrawn
Phase
Not applicable
Enrollment
0
Locations
0
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
Diabetes affects almost 21 million people in the United States. In this study we will test a drug called Pramlintide(Symlin), 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.
Full 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)-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. 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.
Interventions
Treatment arms and agents.
DRUG
Placebo
120 micrograms given subcutaneously before each meal x 3.
Timeline
From registration to results.
First posted
Aug 11, 2008
Study start
Apr 2009
Primary completion
Apr 2011
Study completion
Apr 2011
Results posted
Not reported
Registry updated
Jul 22, 2021
Outcomes
What the study measures.
Primary outcomes
Endogenous glucose production
Time frame · 18 hours
Secondary outcomes
Endogenous VLDL-Triglyceride production
Time frame · 18 hours
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 60 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Type 2 DM study participants will be C-Peptide positive (levels \> 0.3 nmol/L) * Receiving insulin, metformin and/or sulfonylurea/glitinide. * Maintained on stable anti-hypertensive medication. * BMI \< 52 kg/m2. * T2DM for at least 3 months with HBA1C under 10%. Exclusion Criteria: * Receiving TZDs, exenatide, sitagliptin or pramlintide therapy. * Receiving medications known to impair gastric emptying, intestinal motility, glucagon release or corticosteroids. * Triglyceride levels \> 400 mg/dl. * BMI \> 52 kg/m2.
Study locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.