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

Primary Purpose

Glucose Metabolism Disorders, Obesity, Sleeve Gastrectomy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Liquid meal
Solid meal
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Endocrinology, Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Gastric bypass operated patients

Gastric sleeve operated patients

Control arm

Arm Description

Two test days in a randomized, patient-blinded, cross-over design

Two test days in a randomized, patient-blinded, cross-over design

Two test days in a randomized, patient-blinded, cross-over design

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference in gut hormone response after bariatric surgery

Full Information

First Posted
September 3, 2019
Last Updated
August 31, 2021
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04082923
Brief Title
Effect of Meal Texture on Glucose-metabolism and Gut Hormone Response After Bariatric Surgery
Acronym
Obesity
Official Title
Does Meal Texture Have Different Impact on Glucose Metabolism and Intestinal Hormone Response After Gastric Bypass and Sleeve Gastrectomy Operated Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders, Obesity, Sleeve Gastrectomy, Gastric Bypass, Gut Hormones

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gastric bypass operated patients
Arm Type
Other
Arm Description
Two test days in a randomized, patient-blinded, cross-over design
Arm Title
Gastric sleeve operated patients
Arm Type
Other
Arm Description
Two test days in a randomized, patient-blinded, cross-over design
Arm Title
Control arm
Arm Type
Other
Arm Description
Two test days in a randomized, patient-blinded, cross-over design
Intervention Type
Other
Intervention Name(s)
Liquid meal
Intervention Description
Four-hour liquid mixed meal test
Intervention Type
Other
Intervention Name(s)
Solid meal
Intervention Description
Four-hour solid mixed meal test
Primary Outcome Measure Information:
Title
GLP-1 response
Description
GLP-1 response after a liquid meal test compared to a solid meal test
Time Frame
240 minutes
Secondary Outcome Measure Information:
Title
Difference in gut hormone response after bariatric surgery
Time Frame
240 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NOra Hedbäck, MD
Organizational Affiliation
Department of Endocrinology Hvidovre Hospital Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, Hvidovre University Hospital
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
35571890
Citation
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.
Results Reference
derived

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

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