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NCT04452786 Clinical Trial

Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

Glucose Metabolism Disorders Clinical Trial

Official title:
Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04452786
Other study ID # H-19012015
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 5, 2020
Est. completion date April 2023

Study information
Verified date August 2021
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2023
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopic sleeve gastroplasty
Four-hour solid mixed meal test
• Laparoscopic sleeve gastrectomy
Four-hour solid mixed meal test

Locations
Country Name City State
Denmark Department of Endocrinology, Hvidovre University Hospital Copenhagen Hvidovre

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in ghrelin (pg/ml) Changes in ghrelin after a solid meal test compared before and after surgery 240 minutes
Secondary Changes in gut hormone response before and after sugery (pmol/L) 240 minutes
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