NCT01181986

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

Exenatide and Postprandial Endothelial Dysfunction: Effects and Mechanisms

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Carl T. Hayden VA Medical Center · Federal
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 measured by peripheral arterial tonometry (EndoPAT2000, Itamar Inc.). Patients with recent onset (\<3 years) or established (\>5 years, Substudy 1 only) diabetes and impaired sugar tolerance (Substudy 2 only) will be studied. The plan is to complete studies in 75 patients (40 in Substudy 1 and 35 in Substudy 2). In Substudy 1 patients will get twice a day a skin injection of exenatide (Byetta) or identically looking placebo for 10 days, separated by 14-day period. On the next day after each treatemnt period (day 11), they get just one injection and eat a fat-enriched breakfast. A fatty lunch of similar caloric content will be given 4 hours following the breakfast. Endothelial function will be measured just prior to the injection and every 2 hours for total 8 hours. In Substudy 2, patients on 3 different days will get infusion of exenatide withg or without a blocking drug exendin-9, and a control test with placebo without exendin-9. Endothelial function will be measured before the infusion and 2 hours later during the final 15 minutes of the infusion cocktails. Patients will not eat any meal during the test visits.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Exenatide SC	Exenatide 5-10 ug sc BID/10 days
DRUG	Exenatide IV	50 ng/min intravenously for 45 minutes on 2 out of 3 study visits separated by 5-10 days
DRUG	Placebo SC	Placebo sc BID/10days
DRUG	Exendin-9	Primed (6,000 pM/kg), continuous (600 pM/kg) intravenous infusion for 75 minutes on 1 out of 3 study visits.
DRUG	Placebo IV	Intravenous infusion for 45 minutes on 1 out of 3 visits

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-08-16
• Last updated: 2014-05-20
• Results posted: 2014-04-28

Locations

1 site across 1 country: United States