NCT04452786

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

June 19, 2020

Last Update Submit

August 31, 2021

Conditions

Endoscopic Sleeve GastroplastyLaparoscopic Sleeve GastrectomyGut HormonesGlucose Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

  • Changes in ghrelin (pg/ml)

    Changes in ghrelin after a solid meal test compared before and after surgery

    240 minutes

Secondary Outcomes (1)

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

    240 minutes

Study Arms (2)

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

Endoscopic sleeve gastroplastyPROCEDURE

Four-hour solid mixed meal test

Endoscopic sleeve gastroplasity operated patients
Laparoscopic sleeve gastrectomyPROCEDURE

Four-hour solid mixed meal test

Laparoscopic sleeve gastrectomy operated patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital
  • HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
  • BMI\<45

You may not qualify if:

  • Pregnancy or breast feeding
  • Medication affecting the planned examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 30, 2020

Study Start

June 5, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2023

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations

DK(1)