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Trial record 92 of 399 for:    PYY

Investigation of the Effects of Obesity Surgery on Appetitive Behaviour

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02010385
Recruitment Status : Unknown
Verified November 2016 by Carel le Roux, University College Dublin.
Recruitment status was:  Recruiting
First Posted : December 12, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Carel le Roux, University College Dublin

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Roux-en-Y Bariatric Surgery Drug: Octreotide Drug: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Investigation of the Effects of Obesity Surgery on Appetitive Behaviour - Impact of Gut Hormones
Study Start Date : February 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Active Comparator: Octreotide
One subcutaneous injection - 1 mL
Drug: Octreotide
Other Name: Octreotide 100 micrograms/1ml - solution for injection - Hospira - Q64021

Placebo Comparator: Saline
One subcutaneous injection - 1 mL
Drug: Saline
Other Name: Sodium chloride 0.9% W/V injection BP - Fannin - PL 24598/0002

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02010385

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Contact: Sophie Meillon, PhD +353(0)864506131
Contact: Carel le Roux, Pr, MD +353(0)864117842

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University College Dublin Clinical Research Centre Recruiting
Dublin, Ireland, Dublin 4
Contact: Mat Arimin, MD    +353(0)851187100      
Principal Investigator: Carel le Roux, Pr, MD         
Sponsors and Collaborators
University College Dublin
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Principal Investigator: Carel le Roux, Pr, MD UCD Conway institute

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Responsible Party: Carel le Roux, Prof, PhD, MSc, MRCPath, MRCP, MBChB, University College Dublin Identifier: NCT02010385     History of Changes
Other Study ID Numbers: Le Roux 12 June 12
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Carel le Roux, University College Dublin:
Bariatric surgery
Food behaviour
Gut hormones

Additional relevant MeSH terms:
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Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents