Investigating who benefits from bariatric surgery for diabetes
Who Will Benefit From Bariatric Surgery for Diabetes? Using Fat Distribution Measurement, Gut Hormone Profiles and Genetic Data to Predict Diabetes Remission
This study is trying to find out which people with type 2 diabetes or prediabetes will benefit the most from bariatric surgery, specifically the Roux-en-Y gastric bypass.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London, Greater London) |
| Trial ID | NCT03842475 on ClinicalTrials.gov |
What this trial studies
This observational study examines how factors such as fat distribution, genetic markers, and gut hormone responses influence diabetes remission after bariatric surgery, specifically Roux-en-Y gastric bypass (RYGB). It aims to identify which patients with type 2 diabetes or prediabetes are most likely to benefit from the surgery. The study will involve participants who are planning to undergo RYGB and will assess various biological and physiological parameters related to their condition. By understanding these influences, the study seeks to improve patient selection for bariatric surgery.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18-80 with type 2 diabetes or prediabetes who are planning to undergo RYGB and meet specific obesity criteria.
Not a fit: Patients with type 1 diabetes, low fasting C-peptide, or other conditions affecting body fat composition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who are most likely to achieve diabetes remission after bariatric surgery, leading to better treatment outcomes.
How similar studies have performed: Other studies have shown promising results in understanding the predictors of diabetes remission after bariatric surgery, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
London, Greater London
- Imperial College Healthcare NHS Trust — London, Greater London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Tricia Tan, MB ChB — Imperial College London
- Study coordinator: Julia S Kenkre, MB BChir
- Email: imperial.bariatricstudy@nhs.net
- Phone: +44208383242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.