Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

This study has been completed.
Sponsor:
Information provided by:
Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier:
NCT00974272
First received: September 9, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 9, 2009
September 9, 2009
August 2006
November 2008   (final data collection date for primary outcome measure)
Triglyceride concentration in serum [ Time Frame: Before and up to 8-hours post-injection ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function [ Time Frame: Before and up to 8 hours post-injection ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Impaired Glucose Tolerance
  • Drug: Exenatide
    Single subcutaneous injection (10 μg)
    Other Name: Byetta
  • Other: Normal Saline
    Single subcutaneous injection
  • Experimental: Exenatide
    Intervention: Drug: Exenatide
  • Placebo Comparator: Placebo
    Intervention: Other: Normal Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00974272
PR-015
No
Peter D Reaven, MD, Carl T. Hayden VA Medical Center
Carl T. Hayden VA Medical Center
Not Provided
Principal Investigator: Peter D Reaven, MD Phoenix VA Healthcare System
Carl T. Hayden VA Medical Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP