Exenatide and Postprandial Endothelial Dysfunction: Effects and Mechanisms
Reactive Hyperemia Index (RHI) (ratio), 0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2). Exenatide (Subs-study 1): 1.90; Placebo (Sub-study 1): 1.79; Saline+Exenatide (Sub-study 2): 2.24; Saline+Placebo (Sub-study 2): 1.95; Exendin-9+Exenatide (Sub-study 2): 1.99.
As posted on ClinicalTrials.gov (NCT01181986), updated at source May 20, 2014. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Exenatide (Subs-study 1)n=36 | Placebo (Sub-study 1)n=36 | Saline+Exenatide (Sub-study 2)n=32 | Saline+Placebo (Sub-study 2)n=32 | Exendin-9+Exenatide (Sub-study 2)n=32 |
|---|---|---|---|---|
| 1.90(0.005) | 1.79(0.05) | 2.24(0.07) | 1.95(0.07) | 1.99(0.07) |
Percent of participants affected. The most common events the registry lists.
| Event | Exenatide SC (Sub-study 1) | Placebo SC (Sub-study 1) | Saline+Exenatide IV (Sub-study 2) | Saline+Placebo (Sub-study 2) | Exendin-9+Exenatide IV (Sub-study 2) |
|---|---|---|---|---|---|
| Any serious event | 0% | 0% | 0% | 3% | 0% |
| Nausea | 34.1% | 4.9% | 0% | 0% | 0% |
| Headache | 2.4% | 2.4% | 0% | 0% | 0% |
| Diarrhea | 2.4% | 0% | 0% | 0% | 0% |
| Exenatide (Sub-study 1)n=36 | Placebo (Sub-study 1)n=36 |
|---|---|
| 175(14) | 230(14) |
| Exenatide (Sub-study 1)n=36 | Placebo (Sub-study 1)n=36 |
|---|---|
| 115(5) | 136(5) |
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.
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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.