Oral Glucosestimulation After Gastric Bypass Surgery

Not Applicable

Completed

• Conditions: Obesity
• Interventions: 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)

• Registration Number: NCT01851616
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-09
• Last Update Submitted: 2013-05-09
• Study First Posted: 2013-05-10
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

• 6 weeks post gastric bypass surgery,
• non-diabetic patient

Exclusion Criteria

• smoker,
• diabetes,
• gastrointestinal motility disorder,
• medication influencing gastric emptying

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose 25g	25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate)	25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate)
Glucose 10g	10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)	10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)

Primary Outcome Measures

Name	Time	Method
amount of oral glucose leading to increase in satiety hormones	240 min.

Secondary Outcome Measures

Name	Time	Method
Amount of oral glucose leading to clinical signs of dumping	240min.

Trial Locations

Locations (1)

University Hospital of Basel; 🇨🇭 Basel, Switzerland