Status:
COMPLETED
Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
Lead Sponsor:
Carl T. Hayden VA Medical Center
Conditions:
Type 2 Diabetes Mellitus
Impaired Glucose Tolerance
Eligibility:
All Genders
35-70 years
Phase:
PHASE4
Brief 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 postpr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00974272
Start Date
August 1 2006
End Date
November 1 2008
Last Update
September 10 2009
Active Locations (1)
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1
Phoenix VA Medical Center
Phoenix, Arizona, United States, 85012