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Completed

NCT Number: NCT00974272

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.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Phoenix VA Medical Center

Phoenix, Arizona, 85012, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exenatide

Drug

Single subcutaneous injection (10 μg)

Other names: Byetta

Normal Saline

Other

Single subcutaneous injection

Primary outcomes

  1. Triglyceride concentration in serum

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

Secondary outcomes

  1. serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function

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

Sponsors and collaborators

Lead sponsor

Carl T. Hayden VA Medical Center

Fed

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 10, 2009
Registry last updated
Sep 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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