Oral Glucosestimulation After Gastric Bypass Surgery

NCT ID: NCT01851616

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-04-30

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Glucose 25g

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

Glucose 10g

10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)

Group Type: ACTIVE_COMPARATOR

10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)

Intervention Type: DIETARY_SUPPLEMENT

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Beglinger, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Locations

University Hospital of Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

EKBB 298/12/1

Identifier Type: -

Identifier Source: org_study_id