Clinical trial

Who Will Benefit From Bariatric Surgery for Diabetes?

Recruiting now · Not applicable · 1 countries · Registry ID NCT03842475

Recruiting nowNot applicableObservational

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years
SexAll
Healthy volunteersAccepted
ConditionDiabetes Mellitus, Type 2, Obesity

Full registry 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

Treatments and study arms

Roux-en-Y gastric bypass (RYGB)

Procedure

Bariatric surgery

Primary outcomes

Diabetes remission (partial or complete)1 year
Diabetes remission (complete)1 year

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Imperial College Healthcare NHS Trust🇬🇧 London, Greater London, United Kingdom
Julia S Kenkre, MB BChirContact
Tricia Tan, MB ChBPrincipal Investigator