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

Sponsor
University College Dublin
Study ID
NCT07457424
Status
Active Not Recruiting

Conditions

  • Metabolic Disease
  • Obesity & Overweight

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide 1 mg weekly injection — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 17, 2022
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
140 participants (estimated)

Arms

  • Arm: Treatment group
    Subjects with obesity (BMI\>30) who are starting Glucagon-like peptide analogs medicine for obesity treatment
  • Arm: Control with normal weight
    Healthy subjects with normal BMI value
  • Arm: Control with obesity
    Study population with obesity not undergoing any treatment

Primary Outcome Measure

Energy Intake from Liquid Meal Consumption [ Time Frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks ]

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