Status:
COMPLETED
The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes
Lead Sponsor:
Carl T. Hayden VA Medical Center
Collaborating Sponsors:
American Diabetes Association
Amylin Pharmaceuticals, LLC.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-70 years
Phase:
PHASE4
Brief Summary
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 fa...
Detailed Description
Two independent, double-blinded, crossover substudies will be conducted to test the effect of exenatide on daylong post-meal and fasting endothelial function. We will measure endothelial function meas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01181986
Start Date
August 1 2010
End Date
December 1 2012
Last Update
May 20 2014
Active Locations (1)
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1
Phoenix VA Medical Center
Phoenix, Arizona, United States, 85012