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Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

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: NCT04452786
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Nora Elisabeth Hedbäck, Hvidovre University Hospital

Brief Summary:
The investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG).

Condition or disease Intervention/treatment Phase
Endoscopic Sleeve Gastroplasty Laparoscopic Sleeve Gastrectomy Gut Hormones Glucose Metabolism Disorders Procedure: Endoscopic sleeve gastroplasty Procedure: Laparoscopic sleeve gastrectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Endoscopic sleeve gastroplasity operated patients
Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
Procedure: Endoscopic sleeve gastroplasty
Four-hour solid mixed meal test

Laparoscopic sleeve gastrectomy operated patients
Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
Procedure: Laparoscopic sleeve gastrectomy
Four-hour solid mixed meal test




Primary Outcome Measures :
  1. Changes in ghrelin (pg/ml) [ Time Frame: 240 minutes ]
    Changes in ghrelin after a solid meal test compared before and after surgery


Secondary Outcome Measures :
  1. Changes in gut hormone response before and after sugery (pmol/L) [ Time Frame: 240 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital
  • 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
  • BMI<45

Exclusion Criteria:

  • 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): NCT04452786


Locations
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Denmark
Department of Endocrinology, Hvidovre University Hospital Recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Nora Hedbäck, MD    +4538620340    nora.elisabeth.hedbaeck.01@regionh.dk   
Contact: Maria S Svane, MD, PHD    +4538620340    maria.saur.svane@regionh.dk   
Sponsors and Collaborators
Hvidovre University Hospital
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Responsible Party: Nora Elisabeth Hedbäck, Principal Investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04452786    
Other Study ID Numbers: H-19012015
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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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