Type 2 Diabetes Mellitus Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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