Hypoglycaemia after eating due to weight-loss surgery Surgery
Conditions
Interventions
This trial is a proof-of-concept, randomised, open-label, two-period crossover trial conducted over 39 days in male and female participants without diabetes who have undergone Roux-en-Y gastric bypass
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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 = 6.5% or > = 48mmol/l at screening blood tests 16. Haemoglobin (Hb) 5 in a scale from 1 to 7) over the last 2 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in Area Under the Curve (AUC)(0-180), fasting and peak glucose levels after MMTT between the two treatment options (canagliflozin 300 mg vs no treatment) after RYGB and SG, 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, 150 and 180 minutes during visits 2 and 4 2. Difference in AUC(0-180) insulin, fasting and peak insulin levels after MMTT between the two treatment options (canagliflozin 300 mg vs no treatment) after RYGB and SG, measured using blood test processed and plasma measured at 0 min (fasting) and at 15 min, 30 min, 60 min, 90 min, 120 min, 150 min and 180 min after MMTT during visits 2 and 4 3. Difference in AUC(0-180) Glucagon Like Peptide-1 (GLP-1), fasting and peak GLP-1 levels after MMTT between the two treatment options (canagliflozin 300 mg vs no treatment) after RYGB and SG, measured using blood test processed and plasma measured at 0 minutes (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after MMTT during visits 2 and 4. 4. Difference in AUC(0-180) c-peptide, fasting and peak c-peptide levels after MMTT between the two treatment options (canagliflozin 300 mg vs no treatment) after RYGB and SG, measured using blood test processed and plasma measured at 0 min (fasting) and at 15 min, 30 min, 60 min, 90 min, 120 min, 150 min and 180 min after MMTT during visits 2 and 4. 5. Difference in AUC(0-180) glucagon, fasting and peak glucagon levels after MMTT between the two treatment options (canagliflozin 300 mg vs no treatment) after RYGB and SG, measured using blood test processed and plasma measured at 0 min (fasting) and at 15 min, 30 min, 60 min, 90 min, 120 min, 150 min and 180 min after MMTT during visits 2 and 4. 6. Difference in the ratio AUC(0-180) insulin/AUC(0-180) glucose after MMTT between the two treatment options (canagliflozin 300 mg vs no treatment) after RYGB and SG, measured using glucose blood results and I | — |
Countries
England, United Kingdom
Outcome results
None listed