An interventional study of Low carbohydrate meals and Standard carbohydrate meals in Bariatric Surgery (Gastric Bypass), sponsored by Amirsalar Samkani. Completed at 1 site in Denmark. Open to participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-21.
Sponsored by Amirsalar Samkani · Not applicable, Interventional, and Basic science
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.
654 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.
This study's enrollment of 10 is below the median of 29 across 479 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →This is the only study on the registry with Amirsalar Samkani as lead sponsor.
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Exclusion Criteria:
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.
Other: Low carbohydrate meals · Other: 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.
Other: Low carbohydrate meals · Other: Standard carbohydrate meals
Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%
Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%
Nadir plasma glucose
Between low carbohydrate meal and standard meal.
Time frame: 0-240 min, 240-480 min
Peak plasma glucose
Between low carbohydrate meal and standard meal.
Time frame: 0-240 min, 240-480 min
Time to nadir glucose
Between low carbohydrate meal and standard meal.
Time frame: 0-240 min, 240-480 min
Time to peak glucose
Between low carbohydrate meal and standard meal.
Time frame: 0-240 min, 240-480 min
Postprandial incremental glucose area
Between low carbohydrate meal and standard meal.
Time frame: 0-240 min, 240-480 min
Postprandial decremental glucose area
Between low carbohydrate meal and standard meal.
Time frame: 0-240 min, 240-480 min
Postprandial incremental insulin area
Between low carbohydrate meal and standard meal.
Time frame: 0-240 min, 240-480 min
Postprandial incremental GLP-1 area
Between low carbohydrate meal and standard meal.
Time frame: 0-240 min, 240-480 min
Time below basline glucose concentrations
Between low carbohydrate meal and standard meal.
Time frame: 0-480 min
Glycemic excursions
Between low carbohydrate meal and standard meal.
Time frame: 0-480 min
The record gives a start of Aug 2015, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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