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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

Tracking Information
First Submitted Date  ICMJE September 16, 2013
First Posted Date  ICMJE September 19, 2013
Last Update Posted Date April 20, 2021
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date October 31, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Weight loss [ Time Frame: Baseline - 4 weeks ]
Weight loss as measured at baseline compared to 4 weeks after infusion or diet
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Glycaemia [ Time Frame: Baseline - 4 weeks ]
As assessed by change in fructosamine and HbA1c levels
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gut Hormones and Roux en Y Gastric Bypass
Official Title  ICMJE Do Gut Hormones Mediate the Beneficial Effects of Roux-en-Y Bypass?
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Obesity
  • Type 2 Diabetes
Intervention  ICMJE
  • Procedure: Roux en Y Gastric Bypass Surgery
  • Other: Gut hormone infusion
  • Other: Placebo infusion
  • Other: Very low calorie diet
Study Arms  ICMJE
  • Active Comparator: Roux en Y Gastric Bypass
    Participants will be those already scheduled to undergo Roux en Y Gastric Bypass Surgery
    Intervention: 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
    Intervention: Other: Gut hormone infusion
  • Placebo Comparator: Placebo infusion
    Saline infusion given subcutaneously for 4 weeks.
    Intervention: Other: Placebo infusion
  • Active Comparator: Very low calorie diet
    Participants will be asked to follow a very low calorie diet for 4 weeks.
    Intervention: Other: Very low calorie diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2021)
190
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2013)
136
Estimated Study Completion Date  ICMJE October 31, 2028
Estimated Primary Completion Date October 31, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tricia Tan, MBChB MRCP t.tan@imperial.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01945840
Other Study ID Numbers  ICMJE MR/K02115X/1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to make IPD available
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen R Bloom, FRS FRCP MD Imperial College London
PRS Account Imperial College London
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP