Oral Glucosestimulation After Gastric Bypass Surgery

University Hospital Basel

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: 10g 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT01851616

EKBB 298/12/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Glucose 25g

Active Comparator group

Description:

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

Treatment:

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

Glucose 10g

Active Comparator group

Description:

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

Treatment:

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