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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082923
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Nora Elisabeth Hedbäck, 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.

Condition or disease Intervention/treatment Phase
Glucose Metabolism Disorders Obesity Sleeve Gastrectomy Gastric Bypass Gut Hormones Other: Liquid meal Other: Solid meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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?
Estimated Study Start Date : September 6, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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




Primary Outcome Measures :
  1. GLP-1 response [ Time Frame: 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 [ Time Frame: 240 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082923


Locations
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Denmark
Department of Endocrinology, Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital

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Responsible Party: Nora Elisabeth Hedbäck, MD, principal inverstigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04082923    
Other Study ID Numbers: H-19027100
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs