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Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974272
First Posted: September 10, 2009
Last Update Posted: September 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Carl T. Hayden VA Medical Center
  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
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

Resource links provided by NLM:


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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 9, 2009
First Posted: September 10, 2009
Last Update Posted: September 10, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Inflammation
Diabetes Mellitus, Type 2
Hyperlipidemias
Hyperlipoproteinemias
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Dyslipidemias
Lipid Metabolism Disorders
Hyperglycemia
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists