Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00974272
• Date of registration: 09/09/2009
• Primary sponsor: Carl T. Hayden VA Medical Center
• Public title: Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
• Scientific title: Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
• Date of first enrolment: August 2006
• Target sample size: 39
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00974272
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Peter D Reaven, MD
• Affiliation: Phoenix VA Healthcare System

Key inclusion & exclusion 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.



Age minimum: 35 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Impaired Glucose Tolerance

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Exenatide

Other: Normal Saline

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

PR-015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors