Study Looking at Cardiovascular Effects of Exenatide, Its Blood Pressure Lowering Effect and Its Mechanisms

What Was Tested

This registered not phased trial tested Exenatide for low blood pressure and orthostatic hypotension.

Exenatide is a new drug which lowers blood sugar (glucose) levels for people with type 2 diabetes.

It had two arms (groups): Exenatide (active comparator) and one (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Background: Glucagon-like peptide-1 (GLP-1) is an incretin hormone secreted from the L-cells of the gut following a meal (1).

GLP-1 therefore plays a part in glucose homeostasis.

The peptide exendin-4 has considerable homology with GLP-1 but is resistant to degradation by the enzyme Dipeptidyl peptidase-4 (DPP-IV) and so has a much longer duration of action.

In addition, considerable weight loss is often observed with GLP-1 agonists in clinical practice, and these drugs are currently being considered in treating obesity, even outside the context of diabetes.

Who Took Part

Enrollment: 8 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Non-obese (BMI 20-27: those with a BMI \> 25 will be excluded if they have a waist circumference \> 90cm),.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: any metabolic or endocrine abnormalities,; taking regular medication.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the low blood pressure and orthostatic hypotension participants took both Exenatide and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2009-09 with completion listed for 2012-12.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 5 secondary outcomes, for example Blood Pressure (BP), Heart Rate (HR), Limb Blood Flow (LBF), Skin Blood Flow and Peripheral resistance.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 8 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; no results are posted to the registry yet, so nothing here describes outcomes.

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