Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

September 9, 2009 updated by: Carl T. Hayden VA Medical Center
The primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia. Secondary goals are to determine whether there are additional improvements in postprandial lipids and lipoproteins and whether (by the reduction of hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the pro-inflammatory potential of the postprandial period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Phoenix VA Medical Center

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

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recently diagnosed type 2 diabetes (within 3 years) on diet or IGT
  • Fasting triglyceride levels >140 and < 400 mg/dl and values varying less than 35% between two screening measurements
  • Normal liver function tests and white blood cell count

Exclusion Criteria:

  • Type 2 Diabetes for > 3 years or HbA1c ≥ 7.5
  • Known or suspected Type 1 Diabetes
  • Any diabetes medications in the past 3 weeks, TZD in the prior 3 months or prior regular use of insulin
  • Creatinine > 2.0 mg/dl or other evidence of active kidney disease
  • Hepatic enzyme elevation > 2x normal
  • Known Nonalcoholic Fatty Liver Disease
  • Malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems
  • Recent history of nausea or vomiting
  • Acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
  • A prior cardiovascular event, stable or unstable angina or other major illness in the past 6 months
  • Current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (>1 g/day)
  • Any lipid lowering therapy in the prior 3 weeks other than a statin medication. Subjects receiving a statin medication must be on a stable dose for at least 2 months prior to participation.

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: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: Normal Saline
Single subcutaneous injection
EXPERIMENTAL: Exenatide
Drug: Exenatide
Single subcutaneous injection (10 μg)
Other Names:
  • Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Triglyceride concentration in serum
Time Frame: Before and up to 8-hours post-injection
Before and up to 8-hours post-injection

Secondary Outcome Measures

Outcome Measure
Time Frame
serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function
Time Frame: Before and up to 8 hours post-injection
Before and up to 8 hours post-injection

Collaborators and Investigators

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

Sponsor

Carl T. Hayden VA Medical Center

Investigators

  • Principal Investigator: Peter D Reaven, MD, Phoenix VA Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2006

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (ESTIMATE)

September 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2009

Last Update Submitted That Met QC Criteria

September 9, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-015

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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