Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

NCT ID: NCT04452786

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-05

Study Completion Date

2023-04-30

Brief Summary

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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

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Conditions

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Endoscopic Sleeve Gastroplasty Laparoscopic Sleeve Gastrectomy Gut Hormones Glucose Metabolism Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Endoscopic sleeve gastroplasty

Intervention Type PROCEDURE

Four-hour solid mixed meal test

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

Group Type OTHER

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Four-hour solid mixed meal test

Interventions

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Endoscopic sleeve gastroplasty

Four-hour solid mixed meal test

Intervention Type PROCEDURE

Laparoscopic sleeve gastrectomy

Four-hour solid mixed meal test

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nora Elisabeth Hedbäck

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Endocrinology, Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-19012015

Identifier Type: -

Identifier Source: org_study_id

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