Effects of Pramlintide on Endogenous Production of Very-low-density-lipoprotein (VLDL)-Triglyceride and Glucose in the Post Prandial State in T2DM

Type 2 Diabetes Clinical Trial

Official title:

Effects of Pramlintide on Endogenous Production of VLDL-Triglyceride and Glucose in the Post Prandial State in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00732147
• Other study ID #: hp-00044094
• Status: Withdrawn
• Phase: N/A
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: July 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Pramlintide acetate
120 micrograms given subcutaneously before each meal X 3.
• Placebo
120 micrograms given subcutaneously before each meal x 3.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Amylin Pharmaceuticals, LLC.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endogenous glucose production		18 hours
Secondary	Endogenous VLDL-Triglyceride production		18 hours