Patients without diabetes after sleeve gastrectomy Nutritional, Metabolic, Endocrine
Conditions
Interventions
This trial is a proof-of-concept, randomised, open-label, crossover trial conducted over 29 days in male and female participants without diabetes who have undergone sleeve gastrectomy (SG).
Participa
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Aged =18 years old 2. =1 year after sleeve gastrectomy (SG) 3. Able to understand written and spoken English 4. Able to give informed consent 5. Happy for their GP to be notified of their study participation
Exclusion criteria
Exclusion criteria: 1. Use of any glucose-lowering medication (including insulin) 2. Adrenal insufficiency and/or substitution with glucocorticoids 3. eGFR =45 ml/min/1.73 m² 4. Weight =50 kg 5. Recent active infection (an active infection will be any infection over the last 10 days) 6. Current use of steroids 7. Known liver cirrhosis or ALT >2 times above the upper normal limit 8. People with allergy or intolerance to the mixed meal tolerance test (e.g., milk protein allergy, lactose and gluten intolerance), to paracetamol or to nuts 9. People who are on regular painkillers (codeine phosphate, paracetamol, morphine or NSAIDS) 10. Other bariatric procedure except for SG 11. Previous revisional bariatric surgery 12. Hb <100 g/l at screening blood tests 13. HbA1C =6.5% or =48 mmol/l at screening blood tests 14. Currently pregnant or breastfeeding 15. Patients with a history of type 1 or type 2 diabetes 16. Patients with a diagnosis of epilepsy 17. Participating in another research study involving intervention within 3 months of screening 18. Having a formal previous diagnosis of postprandial hypoglycaemia 19. Currently on metoclopramide, domperidone or colestyramine as they can affect paracetamol absorption as per SPC (Summary of Product Characteristics) for paracetamol 20. Currently on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia 21. 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 |
|---|---|
| The difference in nadir (lowest) glucose levels after the standardised MMTT with or without a fat-rich preload after SG for a two-period crossover design. Data will be collected at timepoints (minutes) -30’ (immediately before brazil nut consumption), -15, 0 (immediately before MMTT meal consumption), 15, 30, 45, 60, 90, 120, 150, 180 minutes after MMTT consumption. The AUC [(Area Under the Curve) calculated using trapezium rule] will be used for summarising the response to the additional fat-rich preload before the standardized mixed meal tolerance test. Paired t-test or equivalent non-parametric tests will be used to analyse the AUC and the difference in nadir glucose levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Insulin, Glucagon-Like Peptide-1 and paracetamol levels measured using biochemical analysis of blood samples at the following timepoints at visits 1 and 2: immediately before initiation of consumption of the fat-rich preload/water (-30), before (-15) and immediately before (0) the MMTT and 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the MMTT consumption (to correspond with the glucose measurements). 2. Symptoms of hypoglycaemia during the mixed meal tolerance test measured using the Edinburgh Hypoglycaemia Scale (EHS) at visits 1 and 2; timepoints -30 (before consumption of the fat-rich preload/water), -15, 0 (immediately before consumption of MMTT), 15 (after consumption of the last mouthful of the MMTT), 30, 45, 60, 90, 120, 150, 180 minutes. This will be completed at the timepoints above once blood samples have been drawn. 3. Symptoms of dumping measured using the Sigstad dumping score during the mixed meal tolerance test at visits 1 and 2: timepoints -30 (before consumption of the fat-rich preload/ water), -15, 0 (immediately before consumption of MMTT), 15 (after consumption of the last mouthful of the MMTT), 30, 45, 60, 90, 120, 150, 180 minutes. This will be completed at timepoints above once blood samples have been drawn. | — |
Countries
England, United Kingdom
Outcome results
None listed