Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carl T. Hayden VA Medical Center
• Treatments: Exenatide

Criteria

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.