Investigation of the Effects of Obesity Surgery on Appetitive Behaviour

May 20, 2022 updated by: Carel le Roux, University College Dublin

Investigation of the Effects of Obesity Surgery on Appetitive Behaviour - Impact of Gut Hormones

Among all the existing ways to treat obesity (lifestyle, pharmacological), Roux-en-Y gastric bypass (RYGB) surgery is currently the most effective. It results in long term weight loss maintenance, significant remission of obesity-related comorbidities and decreased overall mortality. It also induces changes in gastrointestinal hormones responses, with an increase of anorexigenic hormones GLP-1, and PYY.

Although successful, the mechanisms for RYGB-induced weight loss are not completely understood. The RYGB does result in increased satiation, decreased calorie intake and decreased preferences for sweet and fatty foods. Previous work from our lab has shown using progressive ratio task (PRT) that RYGB specifically decreases the appetitive behaviour for sweet and fat stimuli but not for vegetables. The reasons for this change in appetitive behaviour after the surgery remain unknown. They may be triggered by changes in gut hormones, conditioned taste aversion (negative post-ingestive effects) or changes in serum bile acids levels.

This study aims to assess whether RGYB-induced gut hormone changes contribute to the decrease in appetitive behaviour for sweet and fatty foods observed after the surgery.

This is a double blind controlled study comparing the effect of blocking gut hormones with somatostatin analogue (octreotide) on the appetitive behaviour for sweet-fat candies will be carried out. Appetitive behaviour will be measured using the progressive ratio task.

The investigators hypothesize that blocking the gut hormones in obese patients with RYGB will increase their appetitive behaviour for sweet-fat candies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, Dublin 4
        • University College Dublin Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gastric bypass surgery since at least 6 months

Exclusion Criteria:

  • serious illness
  • pregnancy or breast feeding
  • more than three alcoholic drinks per day
  • substance abuse
  • psychiatric illness
  • significant longstanding heart disease or heart intervention (for example, patients who have had heart attacks, have pacemakers or have had heart surgery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Octreotide
One subcutaneous injection - 1 mL
Drug: Octreotide
Other Names:
  • Octreotide 100 micrograms/1ml - solution for injection - Hospira - Q64021
PLACEBO_COMPARATOR: Saline
One subcutaneous injection - 1 mL
Drug: Saline
Other Names:
  • Sodium chloride 0.9% W/V injection BP - Fannin - PL 24598/0002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progressive ratio breakpoint
Time Frame: One hour
In the Progressive ratio task, the participants click a computer mouse in order to obtain a sweet/fat food reward. The effort required to obtain a reward is progressively increased. The breakpoint refers to the point at which the reward value of the food stimulus is lower than the effort necessary to obtain it and the participant stops pressing the button.
One hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective ratings
Time Frame: One hour
Hunger, fullness, desire in eating and nausea state will be assessed using Visual Analogue Scales (VAS).
One hour
Gut hormones level
Time Frame: One hour
GLP-1, ghrelin, leptin and insulin levels will be measured.
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Dublin

Investigators

  • Principal Investigator: Carel le Roux, Pr, MD, UCD Conway institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (ESTIMATE)

December 12, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Le Roux 12 June 12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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