Oral Glucosestimulation After Gastric Bypass Surgery

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: 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)

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, CH-4031
    • University Hospital of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glucose 25g; 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)
Active Comparator: Glucose 10g; 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying after gastric bypass	Gastric emptying is measured by means of breath test (use of 50 mg 13C-sodium acetate)	240min

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Christoph Beglinger, Prof., University of Basel

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimate): May 10, 2013

Study Record Updates

• Last Update Posted (Estimate): May 10, 2013
• Last Update Submitted That Met QC Criteria: May 9, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: glucose, blood
• Other Study ID Numbers: EKBB 298/12/1