Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Conditions
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Type 2 Diabetes Mellitus, Impaired Glucose Tolerance

Intervention / Treatment
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* Drug: Exenatide
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide<br> | Drug: Exenatide<br>* Single subcutaneous injection (10 μg)<br>* Other names: Byetta;|
| Placebo Comparator: Placebo<br> | Other: Normal Saline<br>* Single subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride concentration in serum |  | Before and up to 8-hours post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function |  | Before and up to 8 hours post-injection |