Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?
- Conditions
- Bariatric Surgery (Gastric Bypass)
- Interventions
- Other: Low carbohydrate mealsOther: Standard carbohydrate meals
- Registration Number
- NCT02665715
- Lead Sponsor
- Amirsalar Samkani
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- Fasting plasma glucose concentration > 7mmol/L
- Critical illness
- Hgb < 6.5 mM
- Pregnancy or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low carbohydrate/Standard carbohydrate Low carbohydrate meals 10 Roux-en-Y gastric bypass operated subjects are tested two days with mixed-meal tests. Each studytest day consist of both breakfast and lunch. Low carbohydrate/Standard carbohydrate Standard carbohydrate meals 10 Roux-en-Y gastric bypass operated subjects are tested two days with mixed-meal tests. Each studytest day consist of both breakfast and lunch. Standard carbohydrate/Low carbohydrate Standard carbohydrate meals 10 Roux-en-Y gastric bypass operated subjects are tested two days with mixed-meal tests. Each studytest day consist of both breakfast and lunch. Standard carbohydrate/Low carbohydrate Low carbohydrate meals 10 Roux-en-Y gastric bypass operated subjects are tested two days with mixed-meal tests. Each studytest day consist of both breakfast and lunch.
- Primary Outcome Measures
Name Time Method Nadir plasma glucose 0-240 min, 240-480 min Between low carbohydrate meal and standard meal.
- Secondary Outcome Measures
Name Time Method Time to nadir glucose 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.
Peak plasma 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.
Postprandial incremental insulin area 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.
Trial Locations
- Locations (1)
Endocrinology Research Center, Hvidovre University Hospital
🇩🇰Hvidovre, Copenhagen, Denmark