NCT03842475 Who Will Benefit From Bariatric Surgery for Diabetes?
| NCT ID | NCT03842475 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 210 participants |
| Start Date | 2018-10-01 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 210 participants in total. It began in 2018-10-01 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Tricia Tan, MB ChB
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT03842475 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03842475 currently recruiting?
Yes, NCT03842475 is actively recruiting participants. Contact the research team at imperial.bariatricstudy@nhs.net for enrollment information.
Where is the NCT03842475 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT03842475 clinical trial?
NCT03842475 is sponsored by Imperial College London. The principal investigator is Tricia Tan, MB ChB at Imperial College London. The trial plans to enroll 210 participants.
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