Prevention of hypoglycaemia in non-diabetic people who have had a gastric bypass Nutritional, Metabolic, Endocrine
Conditions
Interventions
This study is a proof-of-concept, randomised, open label, crossover study conducted in male and female participants without diabetes who have undergone Roux-en-Y gastric bypass (RYGB). The objective o
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old but less than 75 years old 2. Subjects >=1 year after gastric bypass (RYGB) 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. eGFR 2 times above upper normal limit 7. Known primary or secondary hyperaldosteronism 8. Moderate or severe hypertension during screening visit (Systolic Blood Pressure >160 mmHg as average of 3 measurements) 9. Established diagnosis of congestive heart failure 10. Significant peripheral oedema on clinical examination at screening visit 11. People with allergy or intolerance to the mixed meal tolerance test (eg, milk protein allergy, lactose and gluten intolerance) 12. People following a vegan diet (mixed meal tolerance test not suitable for those following a vegan diet) 13. Other bariatric procedure except of RYGB 14. Previous revisional bariatric surgery 15. Currently pregnant or breastfeeding 16. Patients with history of Type 1 or Type 2 Diabetes 17. Patients with diagnosis of Epilepsy 18. HbA1C >=65% or >=48 mmol/l at screening blood tests 19. Haemoglobin (Hb) <100 g/l at screening blood tests 20. Participating in another research study involving intervention within 3 months of screening 21. Having a formal previous diagnosis of postprandial hypoglycaemia 22. Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia 23. Any concurrent condition, in the judgment of investigator and/or sponsor, that could interfere with the safety and study conduct or interpretation of study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nadir (lowest) glucose levels after the standardised mixed meal tolerance test after RYGB measured using blood test in the fasting state (immediately before MMTT) and at 15 min, 30 min, 60 min, 90 min, 120 min, 150 min and 180 min after MMTT ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using blood test in the fasting state (immediately before MMTT) and at 15 min, 30 min, 60 min, 90 min, 120 min, 150 min and 180 min after MMTT ingestion (unless otherwise stated): 1. Fasting and peak glucose level 2. Insulin level 3. GLP-1 level 4. c-peptide level 5. Sigstad score 6. Edinburgh Hypoglycaemia Scale score 7. Amount of glucose (in grams) needed to restore euglycaemia 8. Number of MMTTs needed to be terminated early because of hypoglycaemia (blood glucose or capillary glucose levels =3.0mmol/l) measured using case report forms | — |
Countries
England, United Kingdom
Outcome results
None listed