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Recruiting
NCT05597475
GLP1R-imaging in Post-RYGB Hypoglycemia
Conditions: Obesity, Hypoglycemia Post Gastric Bypass Surgery, Hyperinsulinemic Hypoglycemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 24
Sponsor: Rijnstate Hospital
Location: Netherlands
Summary
In order to evaluate the difference in beta cell mass in patients with and without hyperinsulinemic hypoglycemia after Roux en Y gastric bypass (RYGB) investigators aim to compare quantitative PET imaging of the pancreas between these patient groups.These highly relevant data will provide investigators with more information on the possible role of beta cell mass in the mechanisms of hyperinsulinemic hypoglycemia bariatric surgery.
Eligibility Criteria
Inclusion Criteria:Signed informed consentPatients:- Persisting hyperinsulinemic hypoglycemia after a low-carbohydrate diet and/or insulin suppressive medication for one year.Controls:RYGB at least 2 years agoNormal glucose levels before and after RYGB (fasting glucose between 4 and 6 mmol/l or HbA1c between 20 and 42 mmol/mol)Score ≤ 7 on Sigstad's scoring system (Table 1)Hypoglycemia excluded by 14-day continuous glucose monitoringIndividual matched to HH group on age (± 5 years), sex and BMI at time of inclusion (± 2 kg/m2)Exclusion Criteria:Anti-diabetic medication in the past 6 monthsTreatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors in the past six months.Known liver failure or serum liver values over 2 times normal value at the time of standard laboratory assessment.
Normal values of total bilirubin, γ-GT, ASAT and albumin are <21 μmol, <40 U/l, <30 U/l and 35-50 g/l respectivelyPregnancy or the wish to become pregnant within 6 monthsBreast feedingKidney failure, i.e. calculated creatinine clearance below 40 ml/minAge < 18 yearsNo signed informed consent
Source: ClinicalTrials.gov (NCT05597475). StuddyBuddy aggregates publicly available trial information.