Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04452786

Collaborator

(none)

Enrollment

Location

Arms

33.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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).

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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 :

Jun 5, 2020

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in ghrelin (pg/ml) [240 minutes]
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) [240 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Endocrinology, Hvidovre University Hospital	Copenhagen	Hvidovre	Denmark	2650

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nora Elisabeth Hedbäck, Principal Investigator, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT04452786

Other Study ID Numbers:

H-19012015

First Posted:

Jun 30, 2020

Last Update Posted:

Sep 5, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolic Diseases

Glucose Metabolism Disorders

Study Results

No Results Posted as of Sep 5, 2021