NCT01945840 Gut Hormones and Roux en Y Gastric Bypass
| NCT ID | NCT01945840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2013-10 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2013-10 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Tricia Tan, MBChB MRCP
✉ t.tan@imperial.ac.ukStephen R Bloom, FRS FRCP MD
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT01945840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01945840 currently recruiting?
Yes, NCT01945840 is actively recruiting participants. Contact the research team at t.tan@imperial.ac.uk for enrollment information.
Where is the NCT01945840 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT01945840 clinical trial?
NCT01945840 is sponsored by Imperial College London. The principal investigator is Stephen R Bloom, FRS FRCP MD at Imperial College London. The trial plans to enroll 190 participants.
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