Who Will Benefit From Bariatric Surgery for Diabetes?
Recruiting · NCT03842475 · Observational (researchers observe without assigning treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
Roux-en-Y gastric bypass (RYGB)
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Imperial College Healthcare NHS Trust - London, Greater London, United Kingdom