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Completed

NCT Number: NCT02010385

Investigation of the Effects of Obesity Surgery on Appetitive Behaviour

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.

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Key information

Conditions

Roux-en-Y Bariatric Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin Clinical Research Centre

Dublin, Dublin 4, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Octreotide

Drug

Other names: Octreotide 100 micrograms/1ml - solution for injection - Hospira - Q64021

Saline

Drug

Other names: Sodium chloride 0.9% W/V injection BP - Fannin - PL 24598/0002

Primary outcomes

  1. 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.

Secondary outcomes

  1. Subjective ratings

    Time frame: One hour

    Hunger, fullness, desire in eating and nausea state will be assessed using Visual Analogue Scales (VAS).

  2. Gut hormones level

    Time frame: One hour

    GLP-1, ghrelin, leptin and insulin levels will be measured.

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 12, 2013
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.