Trial record 19 of 19 for:    Open Studies | "Taste Perception"

Investigation of the Effects of Obesity Surgery on Appetitive Behaviour

This study is currently recruiting participants.
Verified December 2013 by University College Dublin
Sponsor:
Information provided by (Responsible Party):
Carel le Roux, University College Dublin
ClinicalTrials.gov Identifier:
NCT02010385
First received: December 9, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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 Intervention
Roux-en-Y Bariatric Surgery
Drug: Octreotide
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Investigation of the Effects of Obesity Surgery on Appetitive Behaviour - Impact of Gut Hormones

Resource links provided by NLM:


Further study details as provided by University College Dublin:

Primary Outcome Measures:
  • Progressive ratio breakpoint [ Time Frame: One hour ] [ Designated as safety issue: No ]
    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:
  • Subjective ratings [ Time Frame: One hour ] [ Designated as safety issue: No ]
    Hunger, fullness, desire in eating and nausea state will be assessed using Visual Analogue Scales (VAS).

  • Gut hormones level [ Time Frame: One hour ] [ Designated as safety issue: No ]
    GLP-1, ghrelin, leptin and insulin levels will be measured.


Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02010385

Contacts
Contact: Sophie Meillon, PhD +353(0)864506131 sophie.meillon@dijon.inra.fr
Contact: Carel le Roux, Pr, MD +353(0)864117842 carel.leroux@ucd.ie

Locations
Ireland
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
Investigators
Principal Investigator: Carel le Roux, Pr, MD UCD Conway institute
  More Information

Publications:
Responsible Party: Carel le Roux, Prof, PhD, MSc, MRCPath, MRCP, MBChB, University College Dublin
ClinicalTrials.gov Identifier: NCT02010385     History of Changes
Other Study ID Numbers: Le Roux 12 June 12
Study First Received: December 9, 2013
Last Updated: December 11, 2013
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by University College Dublin:
RYGB
Bariatric surgery
Taste
Reward
Food behaviour
Gut hormones

Additional relevant MeSH terms:
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 15, 2014