Investigating who benefits from bariatric surgery for diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

• Clazakizumab for adults with high hsCRP at risk for a heart event

  This study tests whether clazakizumab can lower inflammation and reduce cardiovascular risk in adults with high hsCRP and existing risk factors.

  Recruiting at 32 sites Phase 2 Eli Lilly and Company · Huntsville, Alabama and 45 other locations · NCT07783802

• AI-assisted lifestyle plan vs. tirzepatide for obesity with newly diagnosed type 2 diabetes

  This study tests whether an AI-guided lifestyle program can help overweight adults with newly diagnosed type 2 diabetes lose more weight and improve blood sugar control compared with tirzepatide or standard lifestyle care.

  Recruiting at 5 sites Phase 4 The First Affiliated Hospital of Anhui Medical University · Hefei, Anhui and 4 other locations · NCT07697391

• Long-term test of maridebart cafraglutide for obesity and type 2 diabetes

  This extension study tests whether maridebart cafraglutide remains effective and safe for people with obesity and type 2 diabetes who previously completed a parent trial.

  Recruiting at 45 sites Phase 3 Amgen · Gilbert, Arizona and 44 other locations · NCT07684144

• Tirzepatide in real-world Paraguay for obesity and type 2 diabetes

  This study tests tirzepatide in adults in Paraguay to see how it works for weight loss and blood sugar control in everyday clinical practice.

  Recruiting Phase 4 Las Rías Medical Center · Asunción · NCT07588438

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.