Investigation of the Effects of Obesity Surgery on Appetitive Behaviour

NCT02010385 | Completed DMC

• 1 other identifier: Le Roux 12 June 12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Roux-en-Y Bariatric Surgery

Keywords

RYGB; Bariatric surgery; Taste; Reward; Food behaviour; Gut hormones

Outcome Measures

Primary Outcomes (1)

• Progressive ratio breakpoint

  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 Outcomes (2)

• Subjective ratings

  One hour

• Gut hormones level

  One hour

Study Arms (2)

Octreotide

ACTIVE COMPARATOR

One subcutaneous injection - 1 mL

Drug: Octreotide

Saline

PLACEBO COMPARATOR

One subcutaneous injection - 1 mL

Drug: Saline

Interventions

Octreotide DRUG

Also known as: Octreotide 100 micrograms/1ml - solution for injection - Hospira - Q64021

Octreotide

Saline DRUG

Also known as: Sodium chloride 0.9% W/V injection BP - Fannin - PL 24598/0002

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gastric bypass surgery since at least 6 months

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

University College Dublin Clinical Research Centre

Dublin, Dublin 4, Ireland

Location

Related Publications (1)

• 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.

  PMID: 22836034 BACKGROUND

MeSH Terms

Interventions

Octreotide; Sodium Chloride

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Carel le Roux, Pr, MD

  UCD Conway institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, PhD, MSc, MRCPath, MRCP, MBChB

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

IE (1)