Bariatric Surgery (Gastric Bypass)
Conditions
Keywords
Reactive hypoglycemia, Hyperinsulinaemia, Diet, Glucagon-like Peptide-1, Glucagon, Peptide YY, Ghrelin
Brief summary
Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing higher peak blood glucose concentration early after meal intake. In the late postprandial period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In some patients, overt postprandial hypoglycaemia develops, and is typically reported as a complication 1-5 years postoperatively, when maximal weight loss has been obtained. The pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1 (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive hypoglycemia prevented.
Interventions
Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%
Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%
Sponsors
Hvidovre University Hospital
Amirsalar Samkani
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* RYGB operated patients more than 12 month after operation * Stable in weight for at least 3 months (+/- 3 kg) * Plasma glucose below 3.4 mmol/L after screening with test meal (Fresubin drink) or with continuous glucose monitoring
Exclusion criteria
* Fasting plasma glucose concentration \> 7mmol/L * Critical illness * Hgb \< 6.5 mM * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nadir plasma glucose | 0-240 min, 240-480 min | Between low carbohydrate meal and standard meal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to nadir glucose | 0-240 min, 240-480 min | Between low carbohydrate meal and standard meal. |
| Time to peak glucose | 0-240 min, 240-480 min | Between low carbohydrate meal and standard meal. |
| Postprandial incremental glucose area | 0-240 min, 240-480 min | Between low carbohydrate meal and standard meal. |
| Postprandial decremental glucose area | 0-240 min, 240-480 min | Between low carbohydrate meal and standard meal. |
| Peak plasma glucose | 0-240 min, 240-480 min | Between low carbohydrate meal and standard meal. |
| Postprandial incremental GLP-1 area | 0-240 min, 240-480 min | Between low carbohydrate meal and standard meal. |
| Time below basline glucose concentrations | 0-480 min | Between low carbohydrate meal and standard meal. |
| Glycemic excursions | 0-480 min | Between low carbohydrate meal and standard meal. |
| Postprandial incremental insulin area | 0-240 min, 240-480 min | Between low carbohydrate meal and standard meal. |
Countries
Denmark
Outcome results
None listed