Status:
RECRUITING
Who Will Benefit From Bariatric Surgery for Diabetes?
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
18-80 years
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...
Eligibility Criteria
Inclusion
- Bariatric surgery group
- 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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 5 2028
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03842475
Start Date
October 1 2018
End Date
October 5 2028
Last Update
April 19 2023
Active Locations (1)
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1
Imperial College Healthcare NHS Trust
London, Greater London, United Kingdom, W12 0HS