Gut Hormones and Roux en Y Gastric Bypass

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Other: Placebo infusion; Procedure: Roux en Y Gastric Bypass Surgery; Other: Gut hormone infusion; Other: Very low calorie diet

• Registration Number: NCT01945840
• Lead Sponsor: Imperial College London

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Study Start: 2013-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-20
• Primary Completion: 2028-10-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo infusion	Placebo infusion	Saline infusion given subcutaneously for 4 weeks.
Roux en Y Gastric Bypass	Roux en Y Gastric Bypass Surgery	Participants will be those already scheduled to undergo Roux en Y Gastric Bypass Surgery
Gut hormone infusion	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
Very low calorie diet	Very low calorie diet	Participants will be asked to follow a very low calorie diet for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Weight loss	Baseline - 4 weeks	Weight loss as measured at baseline compared to 4 weeks after infusion or diet

Secondary Outcome Measures

Name	Time	Method
Glycaemia	Baseline - 4 weeks	As assessed by change in fructosamine and HbA1c levels

Trial Locations

Locations (1)

NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital; 🇬🇧 London, Greater London, United Kingdom