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Gut Hormones and Roux en Y Gastric Bypass

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ClinicalTrials.gov Identifier: NCT01945840
Recruitment Status : Unknown
Verified September 2013 by Imperial College London.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2013
Last Update Posted : September 19, 2013
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 (high dose) Other: Gut hormone infusion (low dose) Other: Placebo infusion Other: Very low calorie diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 2018
Estimated Study Completion Date : October 2018

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 (high dose)
Infusion of three gut hormones - GLP-1, PYY and oxyntomodulin subcutaneously.
 Other: Gut hormone infusion (high dose)
Experimental: Gut hormone infusion (low dose)
Infusion of three gut hormones - GLP-1, PYY and oxyntomodulin subcutaneously.
 Other: Gut hormone infusion (low dose)
Placebo Comparator: Placebo infusion
Saline infusion given subcutaneously
 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 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index ≤50 kg/m2.
  • Eligible for bariatric surgery under the NHS.
  • Diagnosed with impaired glucose regulation or type 2 diabetes, according to WHO 2011 criteria. For the dose finding study, non-diabetics can also be recruited.
  • Those with diabetes should be stable and well controlled with either diet or one oral hypoglycaemic agent.
  • HbA1c ≤8.0% or 64 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.
  • Unable to give informed consent.
  • Previous bariatric surgery.
  • Unable to undergo fMRI
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
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 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: September 19, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs