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NCT Number: NCT03842475

Who Will Benefit From Bariatric Surgery for Diabetes?

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, Greater London, W12 0HS, United Kingdom

Location status: Recruiting

Location contact

Julia S Kenkre, MB BChir

CONTACT

Tricia Tan, MB ChB

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roux-en-Y Gastric Bypass (RYGB)

Procedure

Bariatric surgery

Primary outcomes

  1. Diabetes remission (partial or complete)

    Time frame: 1 year

  2. Diabetes remission (complete)

    Time frame: 1 year

Secondary outcomes

  1. Waist circumference, waist/hip ratio (cm)

    Time frame: 1 year

  2. Body mass index (kg/m2)

    Time frame: 1 year

  3. Weight loss

    Time frame: 1 year

  4. Change in visceral adipose tissue

    Time frame: 1 year

    Dual Energy Xray Absorptiometry measurement (DEXA)

  5. Change in visceral adipose tissue

    Time frame: 1 year

    Magnetic resonance imaging (MRI) measurement

  6. Change in ectopic fat

    Time frame: 1 year

    MRI measurement

Other outcomes

  1. Change in epigenetic data in tissues.

    Time frame: 1 year

  2. Changes in the transcriptome in tissues

    Time frame: 1 year

  3. Changes in gut hormone profiles

    Time frame: 1 year

  4. Histological scoring of specimens for Non-alcoholic fatty liver disease/Non-alcoholic steatohepatitis

    Time frame: 1 year

  5. Changes in gut microbiome

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Julia S Kenkre, MB BChir

CONTACT

[email protected]

+44208383242

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2028
First posted
Feb 15, 2019
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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