Gut Hormones and Roux en Y Gastric Bypass
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01945840 |
Recruitment Status :
Recruiting
First Posted : September 19, 2013
Last Update Posted : April 20, 2021
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Roux en Y Gastric Bypass
Participants will be those already scheduled to undergo Roux en Y Gastric Bypass Surgery
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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:
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Other: Gut hormone infusion |
Placebo Comparator: Placebo infusion
Saline infusion given subcutaneously for 4 weeks.
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Other: Placebo infusion |
Active Comparator: Very low calorie diet
Participants will be asked to follow a very low calorie diet for 4 weeks.
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Other: Very low calorie diet |
- Weight loss [ Time Frame: Baseline - 4 weeks ]Weight loss as measured at baseline compared to 4 weeks after infusion or diet
- Glycaemia [ Time Frame: Baseline - 4 weeks ]As assessed by change in fructosamine and HbA1c levels

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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 |
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.
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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

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
Contact: Tricia Tan, MBChB MRCP | t.tan@imperial.ac.uk |
United Kingdom | |
NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital | Recruiting |
London, Greater London, United Kingdom | |
Principal Investigator: Stephen R Bloom, PhD |
Principal Investigator: | Stephen R Bloom, FRS FRCP MD | Imperial College London |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |