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

July 18, 2021 updated by: Stephen N. Davis, MBBS, University of Maryland, Baltimore

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Type 2 diabetes patients will receive placebo with 3 meals in experimental period.
Drug: Placebo
120 micrograms given subcutaneously before each meal x 3.
EXPERIMENTAL: 1
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 Names:
  • Symlin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endogenous glucose production
Time Frame: 18 hours
18 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Endogenous VLDL-Triglyceride production
Time Frame: 18 hours
18 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

Amylin Pharmaceuticals, LLC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (ESTIMATE)

August 11, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 18, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hp-00044094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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