Who Will Benefit From Bariatric Surgery for Diabetes?

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Procedure: Roux-en-Y gastric bypass (RYGB)

• Study Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

• Study Contact: Name: Julia S Kenkre, MB BChir; Phone Number: +44208383242; Email: imperial.bariatricstudy@nhs.net

Study Locations

• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, W12 0HS
      • Recruiting
      • Imperial College Healthcare NHS Trust
      • Contact: Julia S Kenkre, MB BChir
      • Principal Investigator: Tricia Tan, MB ChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Up to 150 patients recruited to completion from Imperial Weight Centre. Up to 60 healthy volunteers

Description

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 β-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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical cohort; Patients with type 2 diabetes undergoing Roux-en-Y gastric bypass surgery	Procedure: Roux-en-Y gastric bypass (RYGB); Bariatric surgery
Control; Healthy volunteers with normal body mass index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diabetes remission (partial or complete)	1 year
Diabetes remission (complete)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss		1 year
Waist circumference, waist/hip ratio (cm)		1 year
Body mass index (kg/m2)		1 year
Change in visceral adipose tissue	Dual Energy Xray Absorptiometry measurement (DEXA)	1 year
Change in visceral adipose tissue	Magnetic resonance imaging (MRI) measurement	1 year
Change in ectopic fat	MRI measurement	1 year

Other Outcome Measures

Outcome Measure	Time Frame
Change in epigenetic data in tissues.	1 year
Changes in the transcriptome in tissues	1 year
Changes in gut hormone profiles	1 year
Histological scoring of specimens for Non-alcoholic fatty liver disease/Non-alcoholic steatohepatitis	1 year
Changes in gut microbiome	1 year

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Tricia Tan, MB ChB, Imperial College London

Publications and helpful links

General Publications

• Kenkre JS, Ahmed AR, Purkayastha S, Malallah K, Bloom S, Blakemore AI, Prevost AT, Tan T. Who will benefit from bariatric surgery for diabetes? A protocol for an observational cohort study. BMJ Open. 2021 Feb 10;11(2):e042355. doi: 10.1136/bmjopen-2020-042355.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): October 5, 2028

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRAS:231300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No