Oral Glucosestimulation After Gastric Bypass Surgery

Study Overview
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Brief Summary
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The objective of this study is to examine gastric emptying and satiety hormones after oral glucose stimulation in 2 different concentrations in morbidly obese patients after Roux-en-Y-gastric-Bypass.

Detailed Description
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After gastric bypass many patients suffer from early and/or late dumping syndrome as a reaction to carbohydrate rich meals. Gastric emptying after bypass is accelerated and nutrition enters the intestine faster, which leads to osmotically driven fluid shifts from the blood to the lumen. Late dumping occurs 1-3 h after eating, and is caused by hyperinsulinemia and is therefore characterized by symptoms of hypoglycemia like weakness, sweating, and dizziness. Many people have both types. In most studies examining satiety hormones after oral glucose stimulation in non-operated patients, glucose loads of 50-75g are used. For a measurable GLP-1 rise a threshold of 2 kcal/min. at the intestine is needed. After gastric bypass gastric emptying is accelerated and less glucose is necessary to reach this threshold. The threshold load and tolerable load without dumping symptoms is not yet know.

Official Title
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Oral Glucosestimulation After Gastric Bypass Surgery

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: 25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate)
* Dietary Supplement: 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 weeks post gastric bypass surgery, non-diabetic patient Exclusion Criteria: smoker, diabetes, gastrointestinal motility disorder, medication influencing gastric emptying

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucose 25g<br>25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate) | Dietary Supplement: 25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate)<br> <br> |
| Active Comparator: Glucose 10g<br>10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate) | Dietary Supplement: 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of oral glucose leading to increase in satiety hormones |  | 240 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of oral glucose leading to clinical signs of dumping |  | 240min. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose, blood