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Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

Primary Purpose

Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, Gut Hormones

Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Endoscopic sleeve gastroplasty
Laparoscopic sleeve gastrectomy
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endoscopic Sleeve Gastroplasty

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Endocrinology, Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Endoscopic sleeve gastroplasity operated patients

Laparoscopic sleeve gastrectomy operated patients

Arm Description

Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery

Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery

Outcomes

Primary Outcome Measures

Changes in ghrelin (pg/ml)
Changes in ghrelin after a solid meal test compared before and after surgery

Secondary Outcome Measures

Changes in gut hormone response before and after sugery (pmol/L)

Full Information

First Posted
June 19, 2020
Last Updated
August 31, 2021
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04452786
Brief Title
Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
Official Title
Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of participants
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, Gut Hormones, Glucose Metabolism Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic sleeve gastroplasity operated patients
Arm Type
Other
Arm Description
Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
Arm Title
Laparoscopic sleeve gastrectomy operated patients
Arm Type
Other
Arm Description
Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
Intervention Type
Procedure
Intervention Name(s)
Endoscopic sleeve gastroplasty
Intervention Description
Four-hour solid mixed meal test
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sleeve gastrectomy
Intervention Description
Four-hour solid mixed meal test
Primary Outcome Measure Information:
Title
Changes in ghrelin (pg/ml)
Description
Changes in ghrelin after a solid meal test compared before and after surgery
Time Frame
240 minutes
Secondary Outcome Measure Information:
Title
Changes in gut hormone response before and after sugery (pmol/L)
Time Frame
240 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
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

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Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

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