Do Gut Hormones Mediate the Beneficial Effects of Roux-en-Y Bypass?
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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• 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.
Locations
Other Locations
United Kingdom
NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital
RECRUITING
London
Contact Information
Primary
Tricia Tan, MBChB MRCP
t.tan@imperial.ac.uk
Time Frame
Start Date: 2013-10
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 190
Treatments
Active_comparator: Roux en Y Gastric Bypass
Participants will be those already scheduled to undergo Roux en Y Gastric Bypass Surgery
Experimental: Gut hormone infusion
Infusion of three gut hormones (GLP-1, PYY and oxyntomodulin) subcutaneously for 4 weeks as below:~* Combination of GLP-1/OXM/PYY (GOP)~* Single GLP-1~* Single OXM~* Single PYY~* Combination of GLP-1 and OXM~* Combination of GLP-1 and PYY~* Combination of OXM and PYY
Placebo_comparator: Placebo infusion
Saline infusion given subcutaneously for 4 weeks.
Active_comparator: Very low calorie diet
Participants will be asked to follow a very low calorie diet for 4 weeks.
Related Therapeutic Areas
Sponsors
Leads: Imperial College London