Effects of Pramlintide on Endogenous Production of Very-Low-Density-Lipoprotein (VLDL)-Triglyceride and Glucose in the Post Prandial State in T2DM - Full Text View

Sponsors and Collaborators:	Vanderbilt University Amylin Pharmaceuticals, Inc.
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00732147

Purpose

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.

Condition	Intervention
Type 2 Diabetes	Drug: Pramlintide acetate Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose Pramlintide Pramlintide acetate

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Endogenous glucose production [ Time Frame: 18 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endogenous VLDL-Triglyceride production [ Time Frame: 18 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	April 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Type 2 diabetes patients will receive placebo with 3 meals in experimental period.	Drug: Placebo 120 micrograms given subcutaneously before each meal x 3.
1: Experimental 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.

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:

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.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732147

Contacts

Contact: Donna B. Tate, MS

615-936-1824

donna.tate@vanderbilt.edu

Locations

United States, Tennessee
VAnderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Antoinette Richardson, BSN 615-936-1824 antoinette.richardson@vanderbilt.edu
Contact: Donna Tate, MS 615-936-1824 donna.tate@vanderbilt.edu

Sponsors and Collaborators

Vanderbilt University

Amylin Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Stephen N. Davis, MD

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University ( Stephen N. Davis )
Study ID Numbers:	Pramlintide-080157
Study First Received:	August 6, 2008
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00732147 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

triglycerides
endogenous
glucose
production

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Pramlintide
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Pramlintide
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2009