Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ghrelin (pg/ml)
Time Frame: 240 minutes
Changes in ghrelin after a solid meal test compared before and after surgery
240 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in gut hormone response before and after sugery (pmol/L)
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

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)

June 5, 2020

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 26, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

September 5, 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-19012015

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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