Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974272
• Other study ID #: PR-015
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2009
• Last updated: September 9, 2009
• Start date: August 2006
• Est. completion date: November 2008

Study information

• Verified date: September 2009
• Source: Carl T. Hayden VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Hyperlipidemias
• Impaired Glucose Tolerance
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Exenatide
Single subcutaneous injection (10 µg)

Other:
• Normal Saline
Single subcutaneous injection

Locations

Country	Name	City	State
United States	Phoenix VA Medical Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Carl T. Hayden VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride concentration in serum		Before and up to 8-hours post-injection	No
Secondary	serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function		Before and up to 8 hours post-injection	No