The effect of consuming a fat-rich snack before a meal on blood sugar levels in people without diabetes after weight loss surgery
- Conditions
- Patients without diabetes after sleeve gastrectomyNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN16600471
- Lead Sponsor
- niversity of Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method