Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.

What Was Tested

In this phase 1 trial, researchers set out to test Liraglutide.

To investigate the effect of liraglutide on vascular injury induced hypoglycemia in patients with type 1 diabetes mellitus.

The vascular damage is evaluated at investigating the changes of endothelial function.

It had two arms (groups): one (experimental) and Vitamine C (experimental).

The registry classes the interventions as drug.

More on the Plan

To investigate the effect of antioxidants (Vitamin C) on the vascular damage induced hypoglycemia in patients with type 1 diabetes.

The vascular injury was evaluated in the same way as main objective.

Checking the existence of a peripheral response to the action of GLP-1 due to oxidative stress.

Who Took Part

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Informed and signed consent obtained before any trial-related activity . ( Trial-related activities are those procedures that were not performed during routine medical examination of the patient) . Diagnosis of type 1 diabetes. Patients who do not have autonomic dysfunction , defined by ( 1). Patients not showing episodes of hypoglycemia unawareness based on the methods of Gold et al (2) . Patients without microvascular complications of diabetes.

The full record lists 11 inclusion and 3 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study some related products; clinical diagnosis of type 2 diabetes.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2014-05 with completion listed for 2015-05.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery (time frame: 8 weeks).

It also tracked 1 secondary outcome, for example Oxidative stress markers.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.