Clinical trial NCT03842475: Who Will Benefit From Bariatric Surgery for Diabetes?
Official title: Who Will Benefit From Bariatric Surgery for Diabetes? Using Fat Distribution Measurement, Gut Hormone Profiles and Genetic Data to Predict Diabetes Remission
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2019-02-15
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 150 patients recruited to completion from Imperial Weight Centre. Up to 60 healthy volunteers

Brief 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.


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

Primary outcomes:
measure: Diabetes remission (partial or complete)
timeFrame: 1 year
measure: Diabetes remission (complete)
timeFrame: 1 year
Secondary outcomes:
measure: Waist circumference, waist/hip ratio (cm)
timeFrame: 1 year
measure: Body mass index (kg/m2)
timeFrame: 1 year
measure: Weight loss
timeFrame: 1 year
measure: Change in visceral adipose tissue
timeFrame: 1 year
measure: Change in visceral adipose tissue
timeFrame: 1 year
measure: Change in ectopic fat
timeFrame: 1 year
Other outcomes:
measure: Change in epigenetic data in tissues.
timeFrame: 1 year
measure: Changes in the transcriptome in tissues
timeFrame: 1 year
measure: Changes in gut hormone profiles
timeFrame: 1 year
measure: Histological scoring of specimens for Non-alcoholic fatty liver disease/Non-alcoholic steatohepatitis
timeFrame: 1 year
measure: Changes in gut microbiome
timeFrame: 1 year
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: Greater London
Study officials:
affiliation: Imperial College London
name: Tricia Tan, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.