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Who Will Benefit From Bariatric Surgery for Diabetes?

Sponsor: Imperial College London

NCT ID: NCT03842475

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Roux-en-Y gastric bypass (RYGB) (procedure)
How long the study runs
Study runs about 120 months (dates as stated)
About the drug or intervention
Roux-en-Y gastric bypass (RYGB) — procedure: Bariatric surgery
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 80 Years
Who
All
Number of participants
210
Started
2018-10-01
Last checked
2023-04

Plain English Summary

What is this study?

  • • Testing a new treatment for diabetes mellitus, type 2
  • • Clinical study - 210 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 80 Years
  • • Diagnosed with diabetes mellitus, type 2

Where?

  • • London - Imperial College Healthcare NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Diabetes Mellitus, Type 2Obesity

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 80 Years
  • Who can join: All genders

What the study is looking for

  • ✓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)

Who cannot take part

  • ✗Current pregnancy
  • ✗Inability to give agreement to take part
  • ✗Type 1 diabetes
  • ✗Low fasting C-peptide
  • ✗Secondary diabetes or absence of β-cell function
See the full 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

Where Is This Study? (1 UK site)

Imperial College Healthcare NHS Trust

London W12 0HS, United Kingdom

Recruiting
Site contact (verified)
Tricia Tan, MB ChBPrincipal Investigator

How to Get in Touch

Julia S Kenkre, MB BChir

Sponsor contact

CONTACT

+44208383242 imperial.bariatricstudy@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2023-04