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Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

This study has been completed.
Sponsor:
Information provided by:
Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier:
NCT00974272
First received: September 9, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Impaired Glucose Tolerance
 Drug: Exenatide
Other: Normal Saline
 Phase 4

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
Official Title: Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Resource links provided by NLM:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by Carl T. Hayden VA Medical Center:

Primary Outcome Measures:
  • Triglyceride concentration in serum [ Time Frame: Before and up to 8-hours post-injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function [ Time Frame: Before and up to 8 hours post-injection ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: August 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide Drug: Exenatide
Single subcutaneous injection (10 μg)
Other Name: Byetta
Placebo Comparator: Placebo Other: Normal Saline
Single subcutaneous injection

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974272

Locations
United States, Arizona
Phoenix VA Medical Center
Phoenix, Arizona, United States, 85012
Sponsors and Collaborators
Carl T. Hayden VA Medical Center
Investigators
Principal Investigator: Peter D Reaven, MD Phoenix VA Healthcare System
  More Information

No publications provided by Carl T. Hayden VA Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peter D Reaven, MD, Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier: NCT00974272     History of Changes
Other Study ID Numbers: PR-015
Study First Received: September 9, 2009
Last Updated: September 9, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Inflammation
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Dyslipidemias
Lipid Metabolism Disorders
Pathologic Processes
Hyperglycemia
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013