CONTROL

The CONTROL study - The effect of Canagliflozin 300mg in subjects without diabetes after bariatric surgery, on glucose homeostasis: A randomised cross-over study.

Study Title

Background

Symptoms due to low sugar levels (hypoglycaemia) such as, dizziness, sweating, shaking, hunger and drowsiness are commonly seen in people with diabetes, especially those who use insulin. After weight-loss surgery, these symptoms along with low sugar levels can occur in people without diabetes a few hours after they eat a meal. This happens because after weight loss surgery, some people’s body produces more insulin (a hormone that lowers their sugar levels) than required after eating a meal.

Canagliflozin, a treatment for people with type 2 diabetes, works by reducing the amount of glucose absorbed from the gut as well as by reducing the insulin that the body is producing immediately after a meal.

If this is also the case after weight-loss surgery, then Canagliflozin may be a treatment for people without diabetes who experience low blood sugar levels after weight-loss surgery.

Study Aims

To provide evidence on whether Canagliflozin 300mg could be a potential treatment option for Post Prandial Hyperinsulinaemic Hypoglycaemia (PHH) after bariatric surgery.

Study Summary

This is a single centre, open label randomised crossover study which consists of 5 study visits. This means that 24 eligible participants will be randomly allocated to one of the following treatment groups:

Group A: Canagliflozin at Visit 1, followed by Standard of Care of Visit 3

Group B: Standard of care at Visit 1, followed by Canagliflozin at Visit 3.

We want to know how Canagliflozin affects the blood sugar levels, insulin and hormone levels. To do this we will provide the participant with a milkshake drink at visit 2 and Visit 4. During the study they will wear a glucose monitoring device between Visit 1 and Visit 2 and between Visit 3 and Visit 4 to assess the glucose levels in everyday life.

Study Progress 

End date for recruitment: May 2022

Funding and Sponsorship 

Funder: The Academy of Medical Sciences

Sponsor: University of Leicester

Study Publications

None yet

Research Team

Principle Investigator: Dr Dimitris Papamargaritis          

Trial Manager: Aga Glab

For information about the CONTROL trial, please contact us on the below:

Phone: 0116 258 8633  Email : CONTROL@uhl-tr.nhs.uk