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Investigation of the Relationship Between Peripheral and Central Metabolic Changes Induced by GLP-1 Agonists

Plain-language guide to NCT06818292: not phased randomized trial of Liraglutide, 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06818292
Phase
not phased
Status
completed
Start
2024-10-21
Completion (planned or actual)
2024-12-06
Participants
10 (actual)
Design
randomized, single-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Liraglutide.

This study aims to investigate the acute effects of Liraglutide, a GLP-1 receptor agonist established in the treatment of type 2 diabetes and obesity, on brain metabolism, brain network function, and executive functioning as well as mood in healthy, normal-weight individuals.

Given the emerging evidence of GLP-1's impact on brain function, including the modulation of reward processing and cognitive functions, this study will focus on the physiological changes induced by Liraglutide and their potential implications for brain health.

The overall goal of this study is to assess how acute GLP-1 administration influences systemic and brain metabolism to modulate brain signalling and behaviour.

It had two arms (groups): GLP-1 then Placebo (experimental) and Placebo then GLP-1 (experimental).

The registry classes the interventions as biological.

More on the Plan

These receptors are widely distributed across brain regions, with high densities in the hypothalamus, brain stem, hippocampus, and in reward-related areas such as the ventral tegmental area (VTA) and nucleus accumbens (NAc).

However, the underlying effects of GLP-1 receptor activation on brain metabolism and functional brain networks remain poorly understood.

This study will address several key questions regarding the molecular, cellular, and cognitive changes that occur following the acute administration of Liraglutide.

In particular, the investigation will focus on how GLP-1 administration modulates peripheral and central metabolism and on the influence of changes in brain metabolism on signaling.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 18 years up to 43 years.

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

Examples of who could join: Normal weight at study inclusion (BMI 18.5-25). Generally good physical condition without serious previous illnesses.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: comorbidity: neurological or psychiatric conditions, cognitive impairments, chronic somatic disorders; pregnancy or nursing; current or within the past five years eating disorder, vegan diet or fasting within the past six months.

How the Study Was Run

Design: randomized, crossover and single-blind.

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

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether Liraglutide was given.

Those kept unaware of assignments: participant.

It started in 2024-10-21 with completion listed for 2024-12-06.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Neuropsychology: Processing speed. Neuropsychology: Attention. Neuropsychology: Memory.

It also tracked 14 secondary outcomes, for example Functional MRI, Structural MR imaging, Sleep, Depression, Anxiety and Anhedonia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 10 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 Liraglutide compound page, all human trials.

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.