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Completed

NCT Number: NCT01851616

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Basel

Basel, CH-4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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)

Dietary Supplement

Primary outcomes

  1. amount of oral glucose leading to increase in satiety hormones

    Time frame: 240 min.

Secondary outcomes

  1. Amount of oral glucose leading to clinical signs of dumping

    Time frame: 240min.

Other outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 10, 2013
Registry last updated
May 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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