Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastr... | NCT04452786

Studies
Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

NCT04452786

Sponsor

Hvidovre University Hospital

Status

Withdrawn

Last Update Posted

Sep 5, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Endoscopic Sleeve Gastroplasty
Laparoscopic Sleeve Gastrectomy
Gut Hormones
Glucose Metabolism Disorders

Interventions

Endoscopic sleeve gastroplasty
Laparoscopic sleeve gastrectomy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of participants

Expanded Access Info

Start Date

Jun 5, 2020Actual

Primary Completion Date

Apr 2022Estimated

Completion Date

Apr 2023Estimated

First Submitted Date

Jun 19, 2020

First Submission Date that Met QC Criteria

Jun 26, 2020

First Posted Date

Jun 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2021

Last Update Posted Date

Sep 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nora Elisabeth Hedbäck, Principal Investigator, Hvidovre University HospitalPrincipal Investigator

Lead Sponsor

Hvidovre University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endoscopic sleeve gastroplasity operated patients	Other	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
Laparoscopic sleeve gastrectomy operated patients	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic sleeve gastroplasty	Procedure	Four-hour solid mixed meal test	Endoscopic sleeve gastroplasity operated patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Changes in gut hormone response before and after sugery (pmol/L)		240 minutes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Hvidovre University Hospital		Copenhagen	Hvidovre	2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D044882	Glucose Metabolism Disorders

Ancestor Terms

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided