The effect of canagliflozin on the blood sugar levels of people without diabetes after weight loss surgery

Not Applicable

Completed

• Conditions: Hypoglycaemia after eating due to weight-loss surgery; Surgery

• Registration Number: ISRCTN11342830
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-24
• Study Completion: 2023-07-31
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Age =18 years old but less than 75 years old
2. =1 year after gastric bypass (RYGB) or sleeve gastrectomy (SG)
3. Able to understand written and spoken English
4. Able to give informed consent

Exclusion Criteria

1. Use of any glucose-lowering medication (including insulin)
2. Adrenal insufficiency and/or substitution with glucocorticoids
3. ALT > 1.5 times the upper normal limit
4. Moderate to severe renal impairment (eGFR< = 60 ml/min/1.73m2)
5. Individuals on loop diuretics
6. Participants with established diagnosis of postural hypotension by their GP
7. Recent active infection (over the last 10 days)
8. Current use of steroids
9. Other bariatric procedure except RYGB/SG
10. Previous revisional bariatric surgery
11. Currently pregnant or breastfeeding
12. Females of child-bearing age, unwilling to use contraception during the period of the study
13. Patients with history of Type 1 or Type 2 diabetes
14. Intolerant to the Mixed Meal Tolerance test
15. HbA1C > = 6.5% or > = 48mmol/l at screening blood tests
16. Haemoglobin (Hb) < 100 g/L at screening blood tests
17. Clinical contraindication to Canagliflozin
18. Known osteoporosis
19. Previous history of Fournier’s gangrene
20. History of epilepsy
21. Known foot ulcers/previous amputation
22. Participating in another research study involving intervention within 3 months of screening
23. Having a formal previous diagnosis of postprandial hypoglycaemia
24. Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
25. Participants without established previous diagnosis of postprandial hyperinsulinaemic hypoglycaemia but with symptoms suggestive of frequent (defined as more than once weekly) AND severe postprandial hypoglycaemia at the screening hypoglycaemia questionnaire (severe is defined as at least two symptoms on Edinburgh Hypoglycaemia Scale (EHS) Questionnaire with intensity > 5 in a scale from 1 to 7) over the last 2 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in nadir (lowest) glucose levels between the two treatment options (canagliflozin 300 mg vs no treatment) after the standardised mixed meal test (separate analysis for subjects who have undergone RYGB and for subjects who have undergone SG). For patients who will develop hypoglycaemia during the MMTT (defined as blood glucose levels =3.0 mmol/l) and the test will be stopped for safety reasons, the glucose levels at the time that the test will be completed will be taken into account as the nadir glucose level. Measured using fasting blood glucose tests at 0 minutes followed by seven further glucose blood tests after the standardised MMTT at 15, 30, 60, 90, 120 and 120 minutes during visits 2 and 4.