Gut Hormones and Roux en Y Gastric Bypass

Launched by IMPERIAL COLLEGE LONDON · Sep 16, 2013

Keywords

ClinConnect Summary

This clinical trial, titled "Gut Hormones and Roux en Y Gastric Bypass," is investigating how certain hormones in the gut might change after a specific type of weight-loss surgery called Roux en Y Gastric Bypass. Researchers want to find out if these hormonal changes are linked to some of the health improvements that people experience after surgery, especially relating to obesity and type 2 diabetes.

To participate in this study, individuals must be between 18 to 70 years old and eligible for weight-loss surgery through the NHS. They should have been diagnosed with type 2 diabetes or impaired glucose regulation, and their diabetes must be well-managed with diet or one medication. Participants can expect to undergo various assessments during the study, which may include hormone testing and imaging scans. It’s important to note that certain conditions, like being pregnant or having a history of serious heart disease, could prevent someone from taking part in the trial. If you or someone you know meets these criteria and is interested in how this surgery might help with weight and health, this study could be a valuable opportunity.

Gender

ALL

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