The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes

This study has been completed.
Sponsor:
Collaborators:
American Diabetes Association
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Juraj Koska, Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier:
NCT01181986
First received: August 13, 2010
Last updated: April 10, 2013
Last verified: April 2013

August 13, 2010
April 10, 2013
August 2010
August 2012   (final data collection date for primary outcome measure)
Endothelial function [ Time Frame: Days 1 or 11 of intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01181986 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes
Exenatide and Postprandial Endothelial Dysfunction: Effects and Mechanisms

The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes medication, will improve the function of the innermost part of the arterial wall called the endothelium after a fat-enriched meal and to determine how this occurs. The results of this study will help to determine and understand a novel action of this group of diabetes medications based on the action of naturally occuring gut substances called incretins. This may have a significant impact on cardiovascular health in patients with early and longstanding diabetes.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: Exenatide
    Exenatide 5-10 ug sc BID/10 days
  • Drug: Exenatide
    Exenatide iv for 45 minutes
  • Experimental: Postprandial endothelial dysfunction
    Intervention: Drug: Exenatide
  • Experimental: Fasting endothelial function
    Intervention: Drug: Exenatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
December 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • US Veterans
  • type 2 diabetes mellitus (T2D) diagnosed within 3 years with good glycemic control on diet, metformin, or sulfonylurea agents or combinations of these agents (HbA1c ≤8.0%)
  • T2D diagnosed ≥ 5 years prior to study enrollment
  • Impaired glucose tolerance

Exclusion Criteria:

  • T2D not meeting inclusion above criteria for duration of diabetes or HbA1c values
  • known or suspected T1D (early onset age, low body mass index, lack of family history)
  • TZD use in the prior 3 months
  • prior regular use of insulin
  • Creatinine >2.0 mg/dl or other laboratory or clinical evidence of kidney disease
  • anemia
  • known active liver disease or hepatic enzyme elevation two-and-a half times above normal
  • acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
  • stable or unstable angina or other major illness in the past 6 months
  • Raynaud's disease or any rheumatic disease affecting fingers
  • current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (>1 g/day);
  • subjects receiving lipid lowering or anti-hypertension medications must be on stable doses for at least 2 months prior to participation.
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01181986
1-10-CT-31
No
Juraj Koska, Carl T. Hayden VA Medical Center
Carl T. Hayden VA Medical Center
  • American Diabetes Association
  • Amylin Pharmaceuticals, LLC.
Principal Investigator: Juraj Koska, MD, PhD Phoenix VA Healthcare System
Carl T. Hayden VA Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP