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Gut Hormones and Roux en Y Gastric Bypass

RECRUITINGN/ASponsored by Imperial College London
Actively Recruiting
PhaseN/A
SponsorImperial College London
Started2013-10
Est. completion2028-10-31
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

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

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions3

DiabetesObesityType 2 Diabetes

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