The CONTROL Study
Research type
Research Study
Full title
The effect of Canagliflozin 300mg, in subjects without diabetes after bariatric surgery, on glucose homeostasis (The CONTROL Study): A proof-of-concept, randomised, open-label, two period crossover study.
IRAS ID
263968
Contact name
Dimitris Papamargaritis
Contact email
Sponsor organisation
University of Leicester
Eudract number
2019-004041-32
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
Symptoms due to low sugar levels (hypoglycaemia)a few hours after eating is a common problem after weight loss surgery which can be distressing. Currently there is no good treatment available for this problem. The underlying cause is unclear, however after weight-loss surgery, people with low glucose levels (hypoglycaemia) after a meal produce more than the necessary amount of insulin.
Canagliflozin, a treatment for type 2 diabetes, has been shown to reduce the insulin production after a meal in patients without diabetes. Moreover, in patients without diabetes, the lowest glucose levels 2-3 hours after eating are slightly higher with the use of canagliflozin. If this is also the case after weight-loss surgery, then canagliflozin could be a treatment option for hypoglycaemia after eating due to weight-loss surgery. The objective of this study is to investigate the effect of canagliflozin on glucose, insulin and hormones secreted from the gut in people without diabetes after weight-loss surgery.
Participants will be provided with canagliflozin tablets for 5 days or no treatment. At the 5th day, participants from both groups will drink a milkshake and we will investigate their glucose, insulin and hormonal levels. After 3 weeks without any treatment, participants will receive again for 5 days either canagliflozin or no treatment (opposite to what they received initially) and will undergo another milkshake test. Participants will also wear a glucose monitoring device for the period receiving canagliflozin tablets and the period without treatment which will assess their glucose levels in everyday life.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0123
Date of REC Opinion
1 Jun 2020
REC opinion
Further Information Favourable Opinion