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ACTIVE NOT RECRUITING
NCT07457424

Direct Measurement of Microstructure of Ingestive Behaviour After Initiation of GLP-1 Receptor Agonist Treatment at Maximum Dose (DIGRAT)

Sponsor: University College Dublin

View on ClinicalTrials.gov

Summary

Ingestion of food instigates the release of a battery of enteroendocrine peptide hormones that help control gut motility and digestive secretion. Peptide hormone products of the enteroendocrine L-cell and GLP-1 in particular, play multiple roles in relation to the regulation of pancreatic islet function and gastric emptying and the induction of satiety pathways in the central nervous system The mechanism of action of GLP-1 RAs on food intake reduction is mainly mediated through both peripheral and central nervous system (CNS) pathways. GLP-1 RAs directly stimulates POMC neurons and inhibits neuropeptide-Y (NPY) and Agouti-related peptide (AgRP) neurons in the arcuate nucleus resulting in a reduction in hunger and increases in fullness4. While there were studies which indirectly measured the changes of food preference and eating behaviour in humans after using GLP-1 RAs via visual analogue scales (VAS) or Patient's Experiences Questionnaires the investigators found there is a necessity to conduct the studies to do direct measurements of the changes of food preference and eating behaviour. Direct measures of an altered food selection in humans after using GLP-1 RAs have virtually not been performed likely due to the significant methodological and conceptual challenges they pose to researchers and study design. However, direct measures represent an essential component in the attempt to understand how GLP-1 RAs alters eating and diet selection which is the main reason of conducting this study. This innovative experiment will be a critical and a novel test of the explicit experience of humans with high-sugar high-fat fluids after using GLP-1 RAs and its potential role for the understanding of possible mechanisms determining post-treatment outcome such as weight loss.

Official title: Direct Measurement of Changes in Food Selection and Intake Behaviour After Using the Maximum Dose of GLP-1 Receptor Agonists

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

140

Start Date

2022-02-17

Completion Date

2027-01-31

Last Updated

2026-03-09

Healthy Volunteers

Yes

Interventions

DRUG

semaglutide 1 mg weekly injection

Initiation of semaglutide treatment with weekly injection. The patient starts at 0.25 mg for 4 weeks and then the dose escalates at 0.5 mg. The maximum dose of 1 mg is reached at week 12. The patients decided to undergo the treatment before they were recruited in the study.

Locations (1)

Clinical Research Centre

Dublin, Dublin, Ireland