Diabetes Remission After RYGBP and RYGBP With Fundus Resection
NCT ID: NCT05854875
Last Updated: 2023-05-11
Study Results
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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COMPLETED
NA
24 participants
INTERVENTIONAL
2019-09-22
2023-04-10
Brief Summary
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* Rate of diabetes remission and the role of the gastrointestinal hormones
* Whether fundus resection leads to improved glycemic control
Patients will randomly undergo typical RYGBP or RYGBP with fundus resection. Gastrointestinal hormones profile \[ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), glucagon\], glucose levels and insulin response will be measured preoperatively, at 6 months and at 12 months, during 120-min OGTT.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RYGBP
Laparoscopic Roux en Y Gastric Bypass
Laparoscopic Roux en Y gastric bypass
Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb.
RYGBP + FR
Laparoscopic Roux en Y Gastric Bypass with fundus resection
Laparoscopic Roux en Y gastric bypass with fundus resection
Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb. Fundus resection is further applied in this arm.
Interventions
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Laparoscopic Roux en Y gastric bypass
Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb.
Laparoscopic Roux en Y gastric bypass with fundus resection
Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb. Fundus resection is further applied in this arm.
Eligibility Criteria
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Inclusion Criteria
* type II diabetes mellitus (T2DM)
* duration of T2DM shorter than 8 years
Exclusion Criteria
* type 1 diabetes
* previous gastrointestinal surgeries
* alcohol consumption
* depression
* no compliance
18 Years
60 Years
ALL
No
Sponsors
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University of Patras
OTHER
Responsible Party
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Dimitrios Kehagias
Principal Investigator
Locations
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University of Patras, University Hospital of Patras
Pátrai, Rio, Greece
Countries
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Other Identifiers
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5378/35835
Identifier Type: -
Identifier Source: org_study_id
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