Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Carl T. Hayden VA Medical Center

Status and phase

Completed

Phase 4

Conditions

Impaired Glucose Tolerance

Type 2 Diabetes Mellitus

Treatments

Drug: Exenatide

Other: Normal Saline

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00974272

PR-015

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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.