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Gut Hormones and Roux en Y Gastric Bypass

Sponsor: Imperial College London

NCT ID: NCT01945840

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Roux en Y Gastric Bypass Surgery (procedure), Gut hormone infusion (other), Placebo infusion (other), Very low calorie diet (other)
How long the study runs
Study runs about 180 months (dates as stated)
About the drug or intervention
Roux en Y Gastric Bypass Surgery (procedure)
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 70 Years
Who
All
Number of participants
190
Started
2013-10
Last checked
2021-04

Plain English Summary

What is this study?

  • • Testing a new treatment for obesity
  • • NA - 190 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 70 Years
  • • Diagnosed with obesity

Where?

  • • London - NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This study is designed to investigate whether chronic elevation of glucagon-like peptide-1 (GLP-1), oxyntomodulin and peptide YY (PYY) in combination is responsible for the majority of the metabolic effects of Roux-en-Y gastric bypass (RYGB) including improved glycaemia, increased energy expenditure, reduced food intake, weight loss, reduced preference for high calorie foods and reduced activation in brain reward areas in response to visual food cues.

ObesityType 2 Diabetes

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 70 Years
  • Who can join: All genders

What the study is looking for

  • ✓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.
See the full 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

Where Is This Study? (1 UK site)

NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital

London, United Kingdom

Recruiting
Site contact (verified)
Stephen R Bloom, PhDPrincipal Investigator

How to Get in Touch

Tricia Tan, MBChB MRCP

Sponsor contact

CONTACT

t.tan@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2021-04