Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?

Study Overview
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Brief Summary
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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.

Official Title
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Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?

Conditions
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Bariatric Surgery (Gastric Bypass)

Intervention / Treatment
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* Other: Low carbohydrate meals
* Other: Standard carbohydrate meals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low carbohydrate/Standard carbohydrate<br>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<br>* Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%<br>Other: Standard carbohydrate meals<br>* Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%<br>|
| Experimental: Standard carbohydrate/Low carbohydrate<br>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<br>* Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%<br>Other: Standard carbohydrate meals<br>* Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nadir plasma glucose | Between low carbohydrate meal and standard meal. | 0-240 min, 240-480 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma glucose | Between low carbohydrate meal and standard meal. | 0-240 min, 240-480 min | 
| Time to nadir glucose | Between low carbohydrate meal and standard meal. | 0-240 min, 240-480 min | 
| Time to peak glucose | Between low carbohydrate meal and standard meal. | 0-240 min, 240-480 min | 
| Postprandial incremental glucose area | Between low carbohydrate meal and standard meal. | 0-240 min, 240-480 min | 
| Postprandial decremental glucose area | Between low carbohydrate meal and standard meal. | 0-240 min, 240-480 min | 
| Postprandial incremental insulin area | Between low carbohydrate meal and standard meal. | 0-240 min, 240-480 min | 
| Postprandial incremental GLP-1 area | Between low carbohydrate meal and standard meal. | 0-240 min, 240-480 min | 
| Time below basline glucose concentrations | Between low carbohydrate meal and standard meal. | 0-480 min | 
| Glycemic excursions | Between low carbohydrate meal and standard meal. | 0-480 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reactive hypoglycemia, Hyperinsulinaemia, Diet, Glucagon-like Peptide-1, Glucagon, Peptide YY, Ghrelin