NCT07457424Active, not recruiting
Direct Measurement of Microstructure of Ingestive Behaviour After Initiation of GLP-1 Receptor Agonist Treatment at Maximum Dose (DIGRAT)
Direct Measurement of Changes in Food Selection and Intake Behaviour After Using the Maximum Dose of GLP-1 Receptor Agonists
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 140 (estimated)
- First submitted
- 5 Mar 2024
- Start date
- 17 Feb 2022
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- University College Dublin
- Diseases
- Obesity
- NCT number
- NCT07457424
What you commit to
- Study type: Observational
- Planned participants: 140
- From 17 Feb 2022 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pre-treatment factors impairing the ability to consume meal such as Significant dysphagia
- Gastric outlet obstruction
- Systemic or gastrointestinal condition which may affect food intake or preference
- Pregnancy or lactation (At the beginning of each study visit, a urine pregnancy test will be performed for all female participants).
- Active and significant psychiatric illness including substance misuse
- Significant cognitive or communication issues
- Medications with documented effects on food intake or food preference
- History of significant food allergy and certain dietary restrictions (except for lactose intolerance)
Who the study is looking for
- Age 18 to 75
- Treatment Group: BMI \> 30 kg/m2 and clinically indicated for GLP-1 RA's treatment.
- Controls with obesity (BMI ≥ 30 kg/m2) with no history of GLP-1 RA's treatment.
- Healthy normal weight controls (BMI \< 25 kg/m2) with no history of using GLP-1 RAs
- Independently mobile
- Capacity to consent to participate
Age in the registry: 18 years to 75 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Centre Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.