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Who Will Benefit From Bariatric Surgery for Diabetes?

Who Will Benefit From Bariatric Surgery for Diabetes?

Recruiting
18-80 years
All
Phase N/A

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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.

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 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 details
    Diabetes Mellitus
    Type 2
    Obesity

NCT03842475

Imperial College London

27 January 2024

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