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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carl T. Hayden VA Medical Center
• Collaborators: American Diabetes Association; Amylin Pharmaceuticals, LLC.
• Treatments: Exenatide

Criteria

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.