Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance
• Interventions: Other: Normal Saline; Drug: Exenatide

• Registration Number: NCT00974272
• Lead Sponsor: Carl T. Hayden VA Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-09
• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Last Update Submitted: 2009-09-09
• Study First Posted: 2009-09-10
• Last Update Posted: 2009-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Normal Saline	-
Exenatide	Exenatide	-

Primary Outcome Measures

Name	Time	Method
Triglyceride concentration in serum	Before and up to 8-hours post-injection

Secondary Outcome Measures

Name	Time	Method
serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function	Before and up to 8 hours post-injection

Trial Locations

Locations (1)

Phoenix VA Medical Center; 🇺🇸 Phoenix, Arizona, United States