To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study

What Was Tested

The trial (phase 4) is built around Liraglutide for low blood pressure and orthostatic hypotension.

The investigators are conducting this research to study the effect of Liraglutide on blood pressure.

It had two arms (groups): Liraglutide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Blood pressure will be monitored using the 24 hour Ambulatory Blood Pressure monitor: a device that monitors your blood pressure while you continue normal activity.

It is well known that both diabetes and hypertension cause endothelial dysfunction.

Endothelium is the inner lining of the blood vessels.

When it is functioning, it is supposed to regulate blood clotting, help with the body's immune response, controls the volume of fluid and other substances that pass through the blood vessels.

Who Took Part

11 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women of 18-75 years of age. Patient understands the study procedures, alternative treatments are available, and the risks involved with the study, and voluntarily agree to participate by providing written informed consent.

The full record lists 6 inclusion and 1 exclusion criteria; among the exclusions: 1\. type 1 diabetes and/or history of ketoacidosis determined by medical history.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2014-10 with completion listed for 2016-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors (time frame: Baseline and 8 Weeks).

It also tracked 1 secondary outcome, for example Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 11 people with low blood pressure and orthostatic hypotension.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, Low blood pressure and orthostatic hypotension research.