Changes in Ingestive Behaviour Following Gastric Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The gastric bypass procedure is known to be one of the most successful treatments for morbid obesity and Type 2 diabetes mellitus, and has been shown to decrease appetite, energy intake, body weight and glycemia both in the short and long term. A number of reports hypothesise that these changes may be driven, at least in part, by positive shifts in food preferences following surgery. However, findings are drawn from self-reported dietary intakes which are beset with measurement bias, thus precluding definite conclusions.

The current work aims to directly observe food intake to test the hypothesis that after gastric bypass food intake changes in a manner which leads to beneficial outcomes on body weight when compared to weight stable control participants. Patients (n=32) with a planned gastric bypass procedure will be recruited from Phoenix Health (Ireland and England) and Letterkenny University Hospital (Ireland), alongside control participants (n=32) with no planned weight loss. All subjects will attend the Human Intervention Studies Unit (HISU), Ulster University on five occasions (1-month pre-surgery and 3, 12, 24 and 60 months post-surgery, with controls being time-matched). Study visits will be fully residential involving two overnight stays within the facility during which participants' 24-hour food intake will be covertly measured (7am-11pm Day 2 and breakfast Day 3) and the following procedures undertaken; basal metabolic rate, body composition, bone health, assessment of liking/wanting high fat foods and post-meal gut hormone responses. On each study visit participants will have ad lib access to a range of foods of varying macronutrient composition and which are compatible with their stated food preferences (assessed prior to the start of the study). Changes in all ingestive behaviours will be evaluated over time as compared to the control participants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation of the Effects of Obesity Surgery on Appetitive Behaviour

NCT02010385

Roux-en-Y Bariatric Surgery

COMPLETED NA

Food Preference Following Bariatric Surgery

NCT03363581

Obesity

COMPLETED

Effect of Gastric Bypass on the Absorption of Metformin

NCT01013051

Obesity Gastric Bypass

COMPLETED

The Effects of Glycemic Optimization Before Gastric Bypass Surgery

NCT01353118

Type 2 Diabetes

COMPLETED NA

Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric Bypass

NCT03384303

Morbid Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morbid Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gastric bypass patients

Patients planned to undergo Gastric bypass procedure. Patients will be assessed -1 month, 3-, 24-, 48- and 60 months post surgery.

No interventions assigned to this group

Healthy controls

Healthy controls with no planned weight loss/gain. Control participant assessments will be time-matched with patients.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \>18 years
* Planned gastric bypass surgery (patients only)
* No planned weight loss/gain (controls only)

Exclusion Criteria

Patients

* Significant dysphagia, gastric outlet obstruction or any other factor which prevents consumption of a meal
* Systemic or gastrointestinal condition which may affect food intake or preference
* Pregnancy / lactation
* Significant food allergy or dietary restriction
* Medication with documented effect on food intake or food preference
* Any other physical or psychological condition which would affect the outcome of the study as determined by Phoenix Health care team.

Controls

* Medication with documented effect on food intake / preference or study outcomes
* Pregnancy / lactation
* Significant food allergy or dietary restriction
* Undertaking a weight-loss programme or planning to.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes