The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers

What Was Tested

This registered not phased trial tested CGRP (Calcitonin Gene-Related Peptide).

To investigate the hemodynamic effects of CGRP after glibenclamide administration.

It had two arms (groups): CGRP and glibenclamide (active comparator) and CGRP and placebo (active comparator).

Participants will recieve CGRP infusion after glibenclamide/placebo administration.

Participants will recieve CGRP infusion after glibenclamide/placebo administration.

The registry classes the interventions as drug.

More on the Plan

20 healthy participants will randomly be allocated to receive CGRP infusion followed by glibenclamide or placebo on two different days.

The aim of the study is to investigate the vascular effect of CGRP after glibenclamide administration.

Repeated measurements covering the arteria radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide/placebo administration and CGRP infusion.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Healthy volunteers of both sexes. Women of childbearing potential must use adequate contraception.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: A history of serious somatic disease; daily intake of any medication except contraceptives.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this CGRP (Calcitonin Gene-Related Peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between CGRP (Calcitonin Gene-Related Peptide) and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on CGRP (Calcitonin Gene-Related Peptide), so expectations could not easily colour the readings.

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

It started in 2020-01-20 with completion listed for 2020-08-01.

It ran at 2 sites in Denmark (2).

Its stated primary purpose is other.

What Was Measured

Primary outcome: Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) (time frame: Time of measurements is baseline and repeatedly every 20 min for 240 min).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of CGRP (Calcitonin Gene-Related Peptide) in 20 people.

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 CGRP (Calcitonin Gene-Related Peptide) compound page, all human trials.