Skip to content

Trial · Interventional

CompletedPhase 4Registry data

Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Overview

Status
Completed
Phase
Phase 4
Enrollment
39 participants (actual)
Sponsor
Carl T. Hayden VA Medical Center · Fed
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Aug 2006
Primary completion
Nov 2008
Completion
Nov 2008
First posted
10 Sept 2009 (estimated)
Last update posted
10 Sept 2009 (estimated)
Conditions
Type 2 Diabetes Mellitus · Impaired Glucose Tolerance

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009
  1. Ph 4

    Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

    NCT00974272

    Aug 2006 to Nov 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ExenatideDrug
  • Normal SalineOther

Arms2

  • Experimental

    Exenatide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Triglyceride concentration in serum

    Time frame · Before and up to 8-hours post-injection

Secondary outcomes(1)
  1. serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function

    Time frame · Before and up to 8 hours post-injection

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2010

2 results

Improvement of postprandial endothelial function after a single dose of exenatide in individuals with impaired glucose tolerance and recent-onset type 2 diabetes.

Koska et al. 2010Diabetes carecited by 104

PMID 20200309PMC2858168DOI 10.2337/dc09-1961PUB-20200309

Free to read · publisher termsCC BY-NC-ND2 results

Indexing hint: Randomized controlled trial · 2010

7 results

Exenatide suppresses postprandial elevations in lipids and lipoproteins in individuals with impaired glucose tolerance and recent onset type 2 diabetes mellitus.

Schwartz et al. 2010Atherosclerosiscited by 150

PMID 20557887DOI 10.1016/j.atherosclerosis.2010.05.028PUB-20557887

Full text at the publisher7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 35 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.