Effect of Meal Texture on Glucose-metabolism and Gut Hormone Response After Bariatric Surgery

Not Applicable

Completed

• Conditions: Obesity; Sleeve Gastrectomy; Gastric Bypass; Glucose Metabolism Disorders; Gut Hormones
• Interventions: Other: Liquid meal; Other: Solid meal

• Registration Number: NCT04082923
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The investigators want to evaluate the difference in glucose metabolism and intestinal hormonal response after a liquid meal versus a solid meal in patients after bariatric surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-10
• Study Start: 2019-10-03
• Primary Completion: 2020-12-01
• Study Completion: 2021-05-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Age > 18 years
• RYGB or SG operation > 12 months prior to inclusion
• Weight stable (± 3 kg during the last month)
• HbA1c < 48 mmol/mol before surgery, and no history of diabetes
• HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion

Exclusion Criteria

• Thyrotoxicosis or inadequately treated hypothyreosis
• Hemoglobin < 6.5 mmol/l at inclusion
• Pregnancy or breast feeding
• Medication affecting the planned examinations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gastric sleeve operated patients	Liquid meal	Two test days in a randomized, patient-blinded, cross-over design
Control arm	Liquid meal	Two test days in a randomized, patient-blinded, cross-over design
Gastric bypass operated patients	Liquid meal	Two test days in a randomized, patient-blinded, cross-over design
Control arm	Solid meal	Two test days in a randomized, patient-blinded, cross-over design
Gastric bypass operated patients	Solid meal	Two test days in a randomized, patient-blinded, cross-over design
Gastric sleeve operated patients	Solid meal	Two test days in a randomized, patient-blinded, cross-over design

Primary Outcome Measures

Name	Time	Method
GLP-1 response	240 minutes	GLP-1 response after a liquid meal test compared to a solid meal test

Secondary Outcome Measures

Name	Time	Method
Difference in gut hormone response after bariatric surgery	240 minutes

Trial Locations

Locations (1)

Department of Endocrinology, Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark