Glucose Metabolism Disorders Clinical Trial
Official title:
Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
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Status | Withdrawn |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 |
Verified date | August 2021 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Endocrinology, Hvidovre University Hospital | Copenhagen | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
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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