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Oral Glucosestimulation After Gastric Bypass Surgery

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ClinicalTrials.gov Identifier: NCT01851616
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity 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) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Oral Glucosestimulation After Gastric Bypass Surgery
Study Start Date : January 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. amount of oral glucose leading to increase in satiety hormones [ Time Frame: 240 min. ]

Secondary Outcome Measures :
  1. Amount of oral glucose leading to clinical signs of dumping [ Time Frame: 240min. ]

Other Outcome Measures:
  1. Gastric emptying after gastric bypass [ Time Frame: 240min ]
    Gastric emptying is measured by means of breath test (use of 50 mg 13C-sodium acetate)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851616


Locations
Switzerland
University Hospital of Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph Beglinger, Prof. University of Basel

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01851616     History of Changes
Other Study ID Numbers: EKBB 298/12/1
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013

Keywords provided by University Hospital, Basel, Switzerland:
glucose, blood