Effect of Meal Texture on Glucose-metabolism and Gut Hormone Response After Bariatric Surgery
Obesity
Does Meal Texture Have Different Impact on Glucose Metabolism and Intestinal Hormone Response After Gastric Bypass and Sleeve Gastrectomy Operated Patients?
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedStudy Start
First participant enrolled
October 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedSeptember 1, 2021
August 1, 2021
1.2 years
September 3, 2019
August 31, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
GLP-1 response
GLP-1 response after a liquid meal test compared to a solid meal test
240 minutes
Secondary Outcomes (1)
Difference in gut hormone response after bariatric surgery
240 minutes
Study Arms (3)
Gastric bypass operated patients
OTHERTwo test days in a randomized, patient-blinded, cross-over design
Gastric sleeve operated patients
OTHERTwo test days in a randomized, patient-blinded, cross-over design
Control arm
OTHERTwo test days in a randomized, patient-blinded, cross-over design
Interventions
Four-hour liquid mixed meal test
Four-hour solid mixed meal test
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Weight stable (± 3 kg during the last month)
- HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
You may not qualify if:
- Thyrotoxicosis or inadequately treated hypothyreosis
- Pregnancy or breast feeding
- Medication affecting the planned examinations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Endocrinology, Hvidovre University Hospital
Copenhagen, Hvidovre, 2650, Denmark
Related Publications (1)
Hedback N, Hindso M, Bojsen-Moller KN, Linddal AK, Jorgensen NB, Dirksen C, Moller A, Kristiansen VB, Hartmann B, Holst JJ, Svane MS, Madsbad S. Effect of Meal Texture on Postprandial Glucose Excursions and Gut Hormones After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Front Nutr. 2022 Apr 29;9:889710. doi: 10.3389/fnut.2022.889710. eCollection 2022.
PMID: 35571890DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
NOra Hedbäck, MD
Department of Endocrinology Hvidovre Hospital Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, principal inverstigator
Study Record Dates
First Submitted
September 3, 2019
First Posted
September 10, 2019
Study Start
October 3, 2019
Primary Completion
December 1, 2020
Study Completion
May 1, 2021
Last Updated
September 1, 2021
Record last verified: 2021-08