NCT01945840Recruiting
Gut Hormones and Roux en Y Gastric Bypass
Do Gut Hormones Mediate the Beneficial Effects of Roux-en-Y Bypass?
Source: ClinicalTrials.gov · Last updated 20 Apr 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- First submitted
- 16 Sept 2013
- Start date
- 1 Oct 2013
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Imperial College London
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT01945840
What you commit to
- Study type: Interventional
- Planned participants: 190
- From 1 Oct 2013 to the primary completion date, 31 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Volunteers on anti-coagulants such as warfarin and factor Xa inhibitors will not undergo adipose tissue biopsy.
- 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
Other illness
- 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.
- History of hypersensitivity to any of the components of the subcutaneous infusions.
- 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.
Other
- 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.
- Donated blood during the preceding 3 months or intention to do so before the end of the study.
- Insulin treatment.
- Unable to give informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
Related publications
- The Metabolomic Effects of Tripeptide Gut Hormone Infusion Compared to Roux-en-Y Gastric Bypass and Caloric Restriction.J Clin Endocrinol Metab · 2022 · PMID 34460933
This page is information, not medical advice. Discuss any trial with your doctor.