Recruiting
Gut Hormones and Roux en Y Gastric Bypass
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.
ClinicalTrials.gov IDNCT01945840
PhaseNA
Enrollment190
SponsorImperial College London
Age18 Years
SexALL
Conditions studied
Obesity, Type 2 Diabetes
About this study
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.
Interventions
- Procedure: Roux en Y Gastric Bypass Surgery
- Other: Gut hormone infusion
- Other: Placebo infusion
- Other: Very low calorie diet
Primary outcomes
- Weight loss (Baseline - 4 weeks)
Eligibility information
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
Study locations
- NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital, London, Greater London United Kingdom
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.