Clinical trial NCT00974272: Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
Official title: Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Impaired Glucose Tolerance
Lead sponsor: Carl T. Hayden VA Medical Center
Sponsor class: FED
First posted: 2009-09-10
Enrollment: 39
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Triglyceride concentration in serum
timeFrame: Before and up to 8-hours post-injection
Secondary outcomes:
measure: serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function
timeFrame: Before and up to 8 hours post-injection
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Medical Center
state: Arizona
Study officials:
affiliation: Phoenix VA Healthcare System
name: Peter D Reaven, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz EA, Koska J, Mullin MP, Syoufi I, Schwenke DC, Reaven PD. Exenatide suppresses postprandial elevations in lipids and lipoproteins in individuals with impaired glucose tolerance and recent onset type 2 diabetes mellitus. Atherosclerosis. 2010 Sep;212(1):217-22. doi: 10.1016/j.atherosclerosis.2010.05.028. Epub 2010 May 25.
citation: Koska J, Schwartz EA, Mullin MP, Schwenke DC, Reaven PD. Improvement of postprandial endothelial function after a single dose of exenatide in individuals with impaired glucose tolerance and recent-onset type 2 diabetes. Diabetes Care. 2010 May;33(5):1028-30. doi: 10.2337/dc09-1961. Epub 2010 Mar 3.