K91.1
Conditions
Interventions
Group 1: This study is a monocentric, randomized, non-blinded pilot study including a patient cohort of 30 participants.
The target population of this research project consists of patients who develo
Sponsors
Universitätsklinikum Mannheim- Chirurgische Klinik und Klinik für interdisziplinäre Endoskopie
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 65 years Patients who previously underwent a laparoscopic Roux-en-Y gastric bypass as a primary procedure for the treatment of obesity according to the currently accepted worldwide standard, with a 60 cm biliopancreatic limb and a 150 cm alimentary limb Positive postoperative Sigstad score (>7 points) Endoscopically measured diameter of the gastrojejunostomy of =2.5 cm At least one pre-interventional postprandial hypoglycemic episode with a blood glucose level of <55 mg/dL during continuous glucose monitoring over a two-week period (late dumping syndrome) Medical indication for interventional or surgical narrowing of the gastrojejunostomy for the treatment of dumping syndrome
Exclusion criteria
Exclusion criteria: Age 65 years Patients who underwent a surgical procedure differing from the standard Roux-en-Y gastric bypass described above Previous bariatric surgery other than adjustable gastric banding Lack of capacity to provide informed consent Language barrier preventing adequate information and understanding of the potential consequences of the treatment Expected non-compliance Patients with pre-existing diabetes mellitus prior to the initial Roux-en-Y gastric bypass surgery Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: The primary objective is to objectively assess post-interventional blood glucose levels using continuous glucose monitoring. For this purpose, patients will wear a glucose monitoring sensor for 10 days on multiple occasions. To enable an interindividual comparison, glucose data will be collected during the month prior to surgery/intervention, during the first ten days after surgery/intervention, and three months after surgery/intervention. This approach allows for a direct comparison of glucose profiles over time. Stabilization of blood glucose levels, defined as the absence of a decrease in blood glucose below 55 mg/dL, will be considered a successful outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Secondary outcome measures will include the clinical development of dumping syndrome assessed by the Sigstad score, postoperative/post-interventional weight development measured by total weight loss and changes in BMI, changes in diabetic metabolic status assessed by HbA1c, C-peptide, blood glucose levels, and the HOMA index, nutritional status assessed by albumin and total protein levels, and quality of life assessed by the EYPASCH score. The analysis of the primary and secondary endpoints will be performed after 3 months (blood glucose values) and after a 12-month follow-up period. A long-term follow-up assessment will be conducted after three years. | — |
Countries
Germany
Contacts
Public ContactSusanne Blank
Universitätsklinikum Mannheim
Outcome results
None listed