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

August 31, 2021 updated by: Nora Elisabeth Hedbäck, Hvidovre University Hospital

Does Meal Texture Have Different Impact on Glucose Metabolism and Intestinal Hormone Response After Gastric Bypass and Sleeve Gastrectomy Operated Patients?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Hvidovre
      • Copenhagen, Hvidovre, Denmark, 2650
        • Department of Endocrinology, Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GLP-1 response
Time Frame: 240 minutes
GLP-1 response after a liquid meal test compared to a solid meal test
240 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in gut hormone response after bariatric surgery
Time Frame: 240 minutes
240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 3, 2019

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (ACTUAL)

September 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19027100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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