Who Will Benefit From Bariatric Surgery for Diabetes?

Launched by IMPERIAL COLLEGE LONDON · Feb 14, 2019

Keywords

ClinConnect Summary

This clinical trial, titled "Who Will Benefit From Bariatric Surgery for Diabetes?" is looking at how different factors, like body fat distribution and genetic markers, affect the success of bariatric surgery in helping people with type 2 diabetes. The main goal is to understand who might benefit most from this type of surgery, which can lead to better management or even remission of diabetes symptoms. The study is currently recruiting participants aged 18 to 80 who are either planning to undergo gastric bypass surgery, known as RYGB, and have obesity and type 2 diabetes or prediabetes, or healthy volunteers with a normal weight.

Participants in the bariatric surgery group will need to meet specific criteria, such as being eligible for surgery under NHS guidelines and having a stable weight for at least three months. Healthy volunteers should have a stable weight and a body mass index (BMI) between 19 and 25. Those who take part can expect to contribute to research that may improve diabetes care, but will also need to meet certain health requirements and will not be able to participate if they have conditions like type 1 diabetes or are pregnant. Overall, this study aims to find out how to better help individuals manage their diabetes through surgery and understand the underlying biological factors involved.

Gender

ALL

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