Prevalence of dumping after bariatric surgery

Not Applicable

Completed

• Conditions: Nutritional, Metabolic, Endocrine; Hyperinsulinemic hypoglycaemia, nesidioblastosis, late dumping, satiety, metabolism

• Registration Number: ISRCTN11738149
• Lead Sponsor: Medical Center Leeuwarden

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29937240 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33063157/ results (added 22/10/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33452416/ bile acid kinetics (added 20/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-05-24
• Study Start: 2017-08-03
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Patients who underwent primary Roux-en-Y gastric bypass surgery between 2008 and 2011
2. Age between 18 and 75 years
3. Informed consent

Exclusion Criteria

Patients with diabetes mellitus

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of hyperinsulinemic hypoglycemia after gastric bypass during a 3.5 hour Mixed Meal Tolerance Test (MMTT). Symptoms will be assessed by the Dumping Severity Score and other questionnaires every 30 minutes and blood collection will be performed at baseline and 10, 20, 30, 60, 90, 120, 150, 180 and 210 minutes after the start of the test meal.

Secondary Outcome Measures

Name	Time	Method
1. Sensitivity and specificity of the Dumping Severity Score and other questionnaires for early and late dumping assessed every 30 minutes during the 3.5 hour MMTT<br>2. Plasma incretin (i.e., gastrointestinal hormone) concentrations during the 3.5 hour MMTT with blood collection at baseline and 10, 20, 30, 60, 90, 120, 150, 180 and 210 minutes after the start of the test meal<br>3. Plasma amino acid concentrations during the 3.5 hour MMTT with blood collection at baseline and 10, 20, 30, 60, 90, 120, 150, 180 and 210 minutes after the start of the test meal<br>4. Other blood parameters during the 3.5 hour MMTT with blood collection at baseline and 10, 20, 30, 60, 90, 120, 150, 180 and 210 minutes after the start of the test meal<br>5. Satiety scores, measured every 30 minutes using a visual analogue scale (VAS) during the 3.5 hour MMTT