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RecruitingNCT01945840Updated Apr 20, 2021

Gut Hormones and Roux en Y Gastric Bypass

An interventional study of Roux en Y Gastric Bypass Surgery and Gut hormone infusion in Obesity and Type 2 Diabetes, sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by Imperial College London · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Obesity
  • Type 2 Diabetes
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In context

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
190 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureRoux en Y Gastric Bypass Surgery
  • OtherGut hormone infusion
  • OtherPlacebo infusion
  • OtherVery low calorie diet
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What researchers measure

Primary outcomes

  1. Weight loss

    Weight loss as measured at baseline compared to 4 weeks after infusion or diet

    Time frame: Baseline - 4 weeks

Secondary outcomes

  1. Glycaemia

    As assessed by change in fructosamine and HbA1c levels

    Time frame: Baseline - 4 weeks

07

Study locations

1 of 1 sites recruiting
  • NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital
    London, Greater London, United Kingdom
    • Stephen R Bloom, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • Alexiadou K, Cuenco J, Howard J, Wewer Albrechtsen NJ, Ilesanmi I, Kamocka A, Tharakan G, Behary P, Bech PR, Ahmed AR, Purkayastha S, Wheller R, Fleuret M, Holst JJ, Bloom SR, Khoo B, Tan TM. Proglucagon peptide secretion profiles in type 2 diabetes before and after bariatric surgery: 1-year prospective study. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e001076. doi: 10.1136/bmjdrc-2019-001076. PubMed 32209584 ↗
  • Ilesanmi I, Tharakan G, Alexiadou K, Behary P, Alessimii H, Bovill-Taylor C, Kenkre J, Choudhury S, Doyle C, Purkayastha S, Miras A, Tsironis C, Chahal H, Bloom SR, Oliver NS, Ahmed AR, Khoo B, Tan TM. Roux-en-Y Gastric Bypass Increases Glycemic Variability and Time in Hypoglycemia in Patients With Obesity and Prediabetes or Type 2 Diabetes: A Prospective Cohort Study. Diabetes Care. 2021 Feb;44(2):614-617. doi: 10.2337/dc20-1609. Epub 2020 Dec 17. PubMed 33334806 ↗
  • Behary P, Tharakan G, Alexiadou K, Johnson N, Wewer Albrechtsen NJ, Kenkre J, Cuenco J, Hope D, Anyiam O, Choudhury S, Alessimii H, Poddar A, Minnion J, Doyle C, Frost G, Le Roux C, Purkayastha S, Moorthy K, Dhillo W, Holst JJ, Ahmed AR, Prevost AT, Bloom SR, Tan TM. Combined GLP-1, Oxyntomodulin, and Peptide YY Improves Body Weight and Glycemia in Obesity and Prediabetes/Type 2 Diabetes: A Randomized, Single-Blinded, Placebo-Controlled Study. Diabetes Care. 2019 Aug;42(8):1446-1453. doi: 10.2337/dc19-0449. Epub 2019 Jun 8. PubMed 31177183 ↗
  • Jones B, Sands C, Alexiadou K, Minnion J, Tharakan G, Behary P, Ahmed AR, Purkayastha S, Lewis MR, Bloom S, Li JV, Tan TM. The Metabolomic Effects of Tripeptide Gut Hormone Infusion Compared to Roux-en-Y Gastric Bypass and Caloric Restriction. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e767-e782. doi: 10.1210/clinem/dgab608. PubMed 34460933 ↗

Individual participant data

Plan to share: No — No plan to make IPD available

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01945840
Lead sponsor
Imperial College London
Responsible party
Sponsor
First posted
Sep 19, 2013
Start date
Oct 2013
Primary completion
Oct 31, 2028 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Apr 20, 2021

Study contacts

Tricia Tan, MBChB MRCP
Contact
t.tan@imperial.ac.uk
Stephen R Bloom, FRS FRCP MD
principal investigator · Imperial College London

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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