Oral Glucosestimulation After Gastric Bypass Surgery

Obesity Clinical Trial

Official title:

Oral Glucosestimulation After Gastric Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851616
• Other study ID #: EKBB 298/12/1
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: May 9, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 6 weeks post gastric bypass surgery,

• non-diabetic patient

Exclusion Criteria:

• smoker,

• diabetes,

• gastrointestinal motility disorder,

• medication influencing gastric emptying

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• 25g of 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)

Locations

Country	Name	City	State
Switzerland	University Hospital of Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gastric emptying after gastric bypass	Gastric emptying is measured by means of breath test (use of 50 mg 13C-sodium acetate)	240min	No
Primary	amount of oral glucose leading to increase in satiety hormones		240 min.	No
Secondary	Amount of oral glucose leading to clinical signs of dumping		240min.	No