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

• Sponsor: Hvidovre University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04082923
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Actual Duration (Months): 18.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glucose Metabolism Disorders; Obesity; Sleeve Gastrectomy; Gastric Bypass; Gut Hormones	Other: Liquid meal; Other: Solid meal	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Does Meal Texture Have Different Impact on Glucose Metabolism and Intestinal Hormone Response After Gastric Bypass and Sleeve Gastrectomy Operated Patients?
• Actual Study Start Date: Oct 3, 2019
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Gastric bypass operated patients Two test days in a randomized, patient-blinded, cross-over design	Other: Liquid meal; Four-hour liquid mixed meal test; Other: Solid meal; Four-hour solid mixed meal test
Other: Gastric sleeve operated patients Two test days in a randomized, patient-blinded, cross-over design	Other: Liquid meal; Four-hour liquid mixed meal test; Other: Solid meal; Four-hour solid mixed meal test
Other: Control arm Two test days in a randomized, patient-blinded, cross-over design	Other: Liquid meal; Four-hour liquid mixed meal test; Other: Solid meal; Four-hour solid mixed meal test

Outcome Measures

Primary Outcome Measures

1. GLP-1 response [240 minutes]

   GLP-1 response after a liquid meal test compared to a solid meal test

Secondary Outcome Measures

1. Difference in gut hormone response after bariatric surgery [240 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Endocrinology, Hvidovre University Hospital	Copenhagen	Hvidovre	Denmark	2650

Sponsors and Collaborators

• Hvidovre University Hospital

Investigators

• Principal Investigator: NOra Hedbäck, MD, Department of Endocrinology Hvidovre Hospital Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nora Elisabeth Hedbäck, MD, principal inverstigator, Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT04082923
• Other Study ID Numbers: H-19027100
• First Posted: Sep 10, 2019
• Last Update Posted: Sep 1, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders

Study Results

No Results Posted as of Sep 1, 2021