Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Completed · Phase 4 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Impaired Glucose Tolerance

In brief

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.

Key facts

Study ID

NCT00974272

Run by

Carl T. Hayden VA Medical Center

People needed

39

Starts

2006-08-01

Expected to finish

2008-11-01

Last updated by the study team

2009-09-10

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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