Type 2 Diabetes Clinical Trial
Official title:
Hormonal Regulation of Systolic Blood Pressure in Response to the GLP-1 (Glucagon-Like Peptide-1) Receptor Agonist, Liraglutide.
Purpose:
The purpose of this study is to further study the mechanism by which liraglutide, a
relatively new anti-hyperglycemic medication, might lower blood pressure in patients with
Type 2 diabetes and high blood pressure.
Background: Type 2 diabetes is a worldwide health problem. As the reduction in blood pressure
has been coupled to improvements in overall cardiovascular outcomes, the control of
hypertension has become an important modifiable risk factor in the overall care of the
patient with Type 2 Diabetes, in addition to glycemic control. Recently, several large-scale
clinical trials evaluating the glucose-lowering effects of the anti-hyperglycemic agent,
liraglutide (a glucagon-like peptide-1 receptor agonist), have demonstrated a modest yet
persistent anti-hypertensive effect in patients with Type 2 diabetes.
Study Objectives: Accordingly, the goal of this small study is to understand whether the
blood pressure lowering effect of liraglutide is coupled to the release of vasoactive
mediators which may stimulate natriuresis and/or diuresis and lower systolic blood pressure.
Study Design: Randomized, double-masked, cross-over study with treatment of liraglutide or
placebo for 3 weeks, with an intervening washout period for 3 weeks, and cross-over to
identical treatment with placebo or liraglutide for 3 weeks.
Study Patients: 20 patients with Type 2 Diabetes and Systolic Hypertension
Endpoints: Change in vasoactive hormones, 24-hour ambulatory blood pressure, urinary sodium
excretion patterns.
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