Gut Hormones and Roux en Y Gastric Bypass

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01945840
• Other study ID #: MR/K02115X/1
• Status: Recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: October 31, 2028

Study information

• Verified date: April 2021
• Source: Imperial College London
• Contact: Tricia Tan, MBChB MRCP
• Email: t.tan[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: October 31, 2028
• Est. primary completion date: October 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

Intervention

Procedure:
• Roux en Y Gastric Bypass Surgery

Other:
• Gut hormone infusion

• Placebo infusion

• Very low calorie diet

Locations

Country	Name	City	State
United Kingdom	NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Alexiadou K, Cuenco J, Howard J, Wewer Albrechtsen NJ, Ilesanmi I, Kamocka A, Tharakan G, Behary P, Bech PR, Ahmed AR, Purkayastha S, Wheller R, Fleuret M, Holst JJ, Bloom SR, Khoo B, Tan TM. Proglucagon peptide secretion profiles in type 2 diabetes before and after bariatric surgery: 1-year prospective study. BMJ Open Diabetes Res Care. 2020 Mar;8(1). pii: e001076. doi: 10.1136/bmjdrc-2019-001076. — View Citation

Behary P, Tharakan G, Alexiadou K, Johnson N, Wewer Albrechtsen NJ, Kenkre J, Cuenco J, Hope D, Anyiam O, Choudhury S, Alessimii H, Poddar A, Minnion J, Doyle C, Frost G, Le Roux C, Purkayastha S, Moorthy K, Dhillo W, Holst JJ, Ahmed AR, Prevost AT, Bloom — View Citation

Ilesanmi I, Tharakan G, Alexiadou K, Behary P, Alessimii H, Bovill-Taylor C, Kenkre J, Choudhury S, Doyle C, Purkayastha S, Miras A, Tsironis C, Chahal H, Bloom SR, Oliver NS, Ahmed AR, Khoo B, Tan TM. Roux-en-Y Gastric Bypass Increases Glycemic Variability and Time in Hypoglycemia in Patients With Obesity and Prediabetes or Type 2 Diabetes: A Prospective Cohort Study. Diabetes Care. 2021 Feb;44(2):614-617. doi: 10.2337/dc20-1609. Epub 2020 Dec 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Weight loss as measured at baseline compared to 4 weeks after infusion or diet	Baseline - 4 weeks
Secondary	Glycaemia	As assessed by change in fructosamine and HbA1c levels	Baseline - 4 weeks