Gut Hormones and Roux en Y Gastric Bypass

Sponsor

Imperial College London (Other)

Overall Status

Recruiting

CT.gov ID

NCT01945840

Collaborator

(none)

190

Enrollment

Location

Arms

181

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Type 2 Diabetes	Procedure: Roux en Y Gastric Bypass Surgery Other: Gut hormone infusion Other: Placebo infusion Other: Very low calorie diet	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

190 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Do Gut Hormones Mediate the Beneficial Effects of Roux-en-Y Bypass?

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Oct 31, 2028

Anticipated Study Completion Date :

Oct 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Roux en Y Gastric Bypass Participants will be those already scheduled to undergo Roux en Y Gastric Bypass Surgery	Procedure: 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	Other: Gut hormone infusion
Placebo Comparator: Placebo infusion Saline infusion given subcutaneously for 4 weeks.	Other: Placebo infusion
Active Comparator: Very low calorie diet Participants will be asked to follow a very low calorie diet for 4 weeks.	Other: Very low calorie diet

Outcome Measures

Primary Outcome Measures

Weight loss [Baseline - 4 weeks]
Weight loss as measured at baseline compared to 4 weeks after infusion or diet

Secondary Outcome Measures

Glycaemia [Baseline - 4 weeks]
As assessed by change in fructosamine and HbA1c levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital	London	Greater London	United Kingdom

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator: Stephen R Bloom, FRS FRCP MD, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Imperial College London

ClinicalTrials.gov Identifier:

NCT01945840

Other Study ID Numbers:

MR/K02115X/1

First Posted:

Sep 19, 2013

Last Update Posted:

Apr 20, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hormones

Study Results

No Results Posted as of Apr 20, 2021