Who Will Benefit From Bariatric Surgery for Diabetes?

Obesity Clinical Trial

Official title:

Who Will Benefit From Bariatric Surgery for Diabetes? Using Fat Distribution Measurement, Gut Hormone Profiles and Genetic Data to Predict Diabetes Remission

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842475
• Other study ID #: IRAS:231300
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: October 5, 2028

Study information

• Verified date: April 2023
• Source: Imperial College London
• Contact: Julia S Kenkre, MB BChir
• Phone: +44208383242
• Email: imperial.bariatricstudy[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A study investigating the influence of fat distribution, genetic susceptibility markers for type 2 diabetes (T2DM) and fat distribution, epigenetic and transcriptomic changes and gut hormone responses to a mixed meal on diabetes remission following bariatric surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: October 5, 2028
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Bariatric surgery group

Inclusion Criteria:

• Males and females planning to undergo RYGB
• 18-80 years
• Type 2 diabetes mellitus or prediabetes
• Stable weight for at least 3 months
• Obese (BMI =30kg/m2)
• Eligible for surgery on the National Health Service (NHS) under The National Institute for Health and Care Excellence (NICE) 2014 criteria

Exclusion Criteria:

• Current pregnancy
• Inability to give informed consent
• Type 1 diabetes
• Low fasting C-peptide
• Secondary diabetes or absence of ß-cell function
• Unable to undergo DEXA, cirrhosis, ascites, or other condition that may modify body fat composition e.g. underlying malignancy
• Current smoker
• Participation in another (interventional) trial within the last 3 months
• Unable to understand English Healthy volunteers

Inclusion criteria:

• Aged 18-80 years
• Male or female
• Body mass index 19 - 25 kg/m2
• Stable weight for at least three months

Exclusion criteria:

• Abnormal glucose tolerance and fasting glucose
• History of any medical, 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
• Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study
• Pregnancy or breastfeeding
• Unable to maintain adequate contraception for the duration of the study
• Donated blood during the preceding 3 months or intention to do so before the end of the study
• Current smoker
• Participation in another trial within the last 3 months
• Unable to understand English

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Procedure:
• Roux-en-Y gastric bypass (RYGB)
Bariatric surgery

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London	Greater London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in epigenetic data in tissues.		1 year
Other	Changes in the transcriptome in tissues		1 year
Other	Changes in gut hormone profiles		1 year
Other	Histological scoring of specimens for Non-alcoholic fatty liver disease/Non-alcoholic steatohepatitis		1 year
Other	Changes in gut microbiome		1 year
Primary	Diabetes remission (partial or complete)		1 year
Primary	Diabetes remission (complete)		1 year
Secondary	Waist circumference, waist/hip ratio (cm)		1 year
Secondary	Body mass index (kg/m2)		1 year
Secondary	Weight loss		1 year
Secondary	Change in visceral adipose tissue	Dual Energy Xray Absorptiometry measurement (DEXA)	1 year
Secondary	Change in visceral adipose tissue	Magnetic resonance imaging (MRI) measurement	1 year
Secondary	Change in ectopic fat	MRI measurement	1 year