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Gut Hormones and Roux en Y Gastric Bypass

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ClinicalTrials.gov Identifier: NCT01945840
Recruitment Status : Recruiting
First Posted : September 19, 2013
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief Summary:
The purpose of this study is to assess whether the changes in gut hormones seen following Roux en Y Gastric Bypass surgery are responsible for some of the beneficial effects seen post-operatively.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Procedure: Roux en Y Gastric Bypass Surgery Other: Gut hormone infusion Other: Placebo infusion Other: Very low calorie diet Not Applicable

Detailed Description:
This study is designed to investigate whether chronic elevation of glucagon-like peptide-1 (GLP-1), oxyntomodulin and peptide YY (PYY) in combination is responsible for the majority of the metabolic effects of Roux-en-Y gastric bypass (RYGB) including improved glycaemia, increased energy expenditure, reduced food intake, weight loss, reduced preference for high calorie foods and reduced activation in brain reward areas in response to visual food cues.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Do Gut Hormones Mediate the Beneficial Effects of Roux-en-Y Bypass?
Study Start Date : October 2013
Estimated Primary Completion Date : October 31, 2028
Estimated Study Completion Date : October 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Roux en Y Gastric Bypass
Participants will be those already scheduled to undergo Roux en Y Gastric Bypass Surgery
 Procedure: Roux en Y Gastric Bypass Surgery
Experimental: Gut hormone infusion

Infusion of three gut hormones (GLP-1, PYY and oxyntomodulin) subcutaneously for 4 weeks as below:

  • Combination of GLP-1/OXM/PYY (GOP)
  • Single GLP-1
  • Single OXM
  • Single PYY
  • Combination of GLP-1 and OXM
  • Combination of GLP-1 and PYY
  • Combination of OXM and PYY
 Other: Gut hormone infusion
Placebo Comparator: Placebo infusion
Saline infusion given subcutaneously for 4 weeks.
 Other: Placebo infusion
Active Comparator: Very low calorie diet
Participants will be asked to follow a very low calorie diet for 4 weeks.
 Other: Very low calorie diet


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: Baseline - 4 weeks ]
    Weight loss as measured at baseline compared to 4 weeks after infusion or diet


Secondary Outcome Measures :
  1. Glycaemia [ Time Frame: Baseline - 4 weeks ]
    As assessed by change in fructosamine and HbA1c levels


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Aged 18 - 70 years.
  • Male or female.
  • Eligible for bariatric surgery under the NHS.
  • Diagnosed with impaired glucose regulation or type 2 diabetes, according to WHO 2011 criteria.
  • Those with diabetes should be stable and well controlled with either diet or one oral hypoglycaemic agent.
  • HbA1c ≤9.0% or 74.9 mmol/mol.

Exclusion criteria

  • History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer.
  • Without access at home to a telephone or other factor likely to interfere with ability to participate reliably in the study.
  • Pregnancy or breastfeeding.
  • Smokers.
  • Unable to maintain adequate contraception for the duration of the study and for one month afterwards.
  • History of hypersensitivity to any of the components of the subcutaneous infusions.
  • Donated blood during the preceding 3 months or intention to do so before the end of the study.
  • Insulin treatment.
  • Uncontrolled hypertension.
  • Any other co-morbidity that would compromise the validity of the study or the safety of the participant such as heart failure, clinically apparent cardiovascular disease.
  • Volunteers on anti-coagulants such as warfarin and factor Xa inhibitors will not undergo adipose tissue biopsy.
  • Unable to give informed consent.
  • Previous bariatric surgery.

  • Unable to undergo fMRI due to:

    • Claustrophobia.
    • Pacemaker, metal implant, clips, implanted device, shrapnel or bullet, metal in eyes that precludes magnetic resonance imaging.
    • Significant structural abnormality on magnetic resonance brain scan
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01945840


Contacts
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Contact: Tricia Tan, MBChB MRCP t.tan@imperial.ac.uk

Locations
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United Kingdom
NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital Recruiting
London, Greater London, United Kingdom
Principal Investigator: Stephen R Bloom, PhD         
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Stephen R Bloom, FRS FRCP MD Imperial College London
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01945840    
Other Study ID Numbers: MR/K02115X/1
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs