Investigation of the Effects of Obesity Surgery on Appetitive Behaviour

NCT ID: NCT02010385

Last Updated: 2022-05-23

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Roux-en-Y Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Octreotide

One subcutaneous injection - 1 mL

Group Type ACTIVE_COMPARATOR

Octreotide

Intervention Type DRUG

Saline

One subcutaneous injection - 1 mL

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Interventions

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Octreotide

Intervention Type DRUG

Saline

Intervention Type DRUG

Other Intervention Names

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Octreotide 100 micrograms/1ml - solution for injection - Hospira - Q64021 Sodium chloride 0.9% W/V injection BP - Fannin - PL 24598/0002

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Carel le Roux

Prof, PhD, MSc, MRCPath, MRCP, MBChB

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carel le Roux, Pr, MD

Role: PRINCIPAL_INVESTIGATOR

UCD Conway institute

Locations

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University College Dublin Clinical Research Centre

Dublin, , Ireland

Site Status

Countries

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Ireland

References

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Miras AD, Jackson RN, Jackson SN, Goldstone AP, Olbers T, Hackenberg T, Spector AC, le Roux CW. Gastric bypass surgery for obesity decreases the reward value of a sweet-fat stimulus as assessed in a progressive ratio task. Am J Clin Nutr. 2012 Sep;96(3):467-73. doi: 10.3945/ajcn.112.036921. Epub 2012 Jul 25.

Reference Type BACKGROUND
PMID: 22836034 (View on PubMed)

Other Identifiers

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Le Roux 12 June 12

Identifier Type: -

Identifier Source: org_study_id

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