๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ30kg/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 ฮฒ-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
๐
What it tests
- Roux-en-Y gastric bypass (RYGB)
Imperial College Healthcare NHS Trust
London, United Kingdom
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.