Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT03842475

Who Will Benefit From Bariatric Surgery for Diabetes?

Led by Imperial College London · Updated on 2023-04-19

210

Participants Needed

1

Research Sites

522 weeks

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

N

National Institute for Health Research, United Kingdom

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Who Will Benefit From Bariatric Surgery for Diabetes?

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Planning to undergo Roux-en-Y gastric bypass surgery
  • Age between 18 and 80 years
  • Diagnosis of type 2 diabetes mellitus or prediabetes
  • Stable weight for at least 3 months
  • Obese with body mass index of 30 kg/m2 or higher
  • Eligible for surgery under National Health Service criteria
  • Healthy volunteers aged 18-80 years
  • Healthy volunteers with body mass index between 19 and 25 kg/m2
  • Healthy volunteers with stable weight for at least 3 months
Not Eligible

You will not qualify if you...

  • Current pregnancy
  • Unable to give informed consent
  • Type 1 diabetes
  • Low fasting C-peptide levels
  • Secondary diabetes or absence of beta-cell function
  • Unable to undergo DEXA scan or conditions affecting body fat composition such as cirrhosis, ascites, or malignancy
  • Current smoker
  • Participation in another interventional trial within the last 3 months
  • Unable to understand English
  • Abnormal glucose tolerance or fasting glucose in healthy volunteers
  • Medical conditions or medication use interfering with study participation in healthy volunteers
  • Lack of telephone access or other factors interfering with study participation
  • Breastfeeding
  • Unable to maintain adequate contraception during the study
  • Blood donation in last 3 months or planned during study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Imperial College Healthcare NHS Trust

London, Greater London, United Kingdom, W12 0HS

Actively Recruiting

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Research Team

J

Julia S Kenkre, MB BChir

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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