Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

Hvidovre University Hospital

Status: Withdrawn

Conditions: Laparoscopic Sleeve Gastrectomy; Endoscopic Sleeve Gastroplasty; Glucose Metabolism Disorders; Gut Hormones

Treatments: Procedure: Laparoscopic sleeve gastrectomy; Procedure: Endoscopic sleeve gastroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04452786

H-19012015

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Endoscopic sleeve gastroplasity operated patients

Other group

Description:

Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery

Treatment:

Procedure: Endoscopic sleeve gastroplasty

Laparoscopic sleeve gastrectomy operated patients

Other group

Description:

Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery

Treatment:

Procedure: Laparoscopic sleeve gastrectomy