Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Sponsor

Carl T. Hayden VA Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00974272

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Impaired Glucose Tolerance	Drug: Exenatide Other: Normal Saline	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exenatide	Drug: Exenatide Single subcutaneous injection (10 μg) Other Names: Byetta
Placebo Comparator: Placebo	Other: Normal Saline Single subcutaneous injection

Arm

Intervention/Treatment

Experimental: Exenatide

Drug: Exenatide

Single subcutaneous injection (10 μg)

Other Names:

Byetta

Placebo Comparator: Placebo

Other: Normal Saline

Single subcutaneous injection

Outcome Measures

Primary Outcome Measures

Triglyceride concentration in serum [Before and up to 8-hours post-injection]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.