Who Will Benefit From Bariatric Surgery for Diabetes?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Roux-en-Y gastric bypass (RYGB).
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Obesity. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Who Will Benefit From Bariatric Surgery for Diabetes? Using Fat Distribution Measurement, Gut Hormone Profiles and Genetic Data to Predict Diabetes Remission
Overview
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.
Interventions
- Procedure Roux-en-Y gastric bypass (RYGB)
Bariatric surgery
Primary outcome measures
- Diabetes remission (partial or complete) [Time frame: 1 year]
- Diabetes remission (complete) [Time frame: 1 year]
Secondary outcome measures (6)
- Waist circumference, waist/hip ratio (cm) [Time frame: 1 year]
- Body mass index (kg/m2) [Time frame: 1 year]
- Weight loss [Time frame: 1 year]
- Change in visceral adipose tissue [Time frame: 1 year]
- Change in visceral adipose tissue [Time frame: 1 year]
- Change in ectopic fat [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Imperial College Healthcare NHS Trust — London
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. PMID 33568372
Identifiers
NCT: NCT03842475 · IRAS:231300