GLP1R-imaging in Post-RYGB Hypoglycemia

Launched by RIJNSTATE HOSPITAL · Oct 27, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the differences in a specific type of cell in the pancreas, called beta cells, in people who experience low blood sugar (hypoglycemia) after having a gastric bypass surgery called Roux en Y. The researchers want to understand how the amount of these beta cells might affect the low blood sugar problems some patients face after surgery. To do this, they will use a special imaging technique to compare patients with ongoing hypoglycemia to those who do not have this issue.

To participate in the trial, you must be between 65 and 74 years old and have experienced persistent low blood sugar despite following a low-carb diet or taking medication for at least a year. If you're a control participant, you should have had your gastric bypass surgery at least two years ago and have normal blood sugar levels. All participants will need to provide signed consent to be part of the study. This trial is currently recruiting, and participants can expect to undergo imaging tests and possibly gain insights into their condition while contributing to important research in this area.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent
• Patients:
• • - Persisting hyperinsulinemic hypoglycemia after a low-carbohydrate diet and/or insulin suppressive medication for one year.
• Controls:
• • RYGB at least 2 years ago
• • Normal 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 monitoring
• • Individual 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 months
• • Treatment 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 respectively
• • Pregnancy or the wish to become pregnant within 6 months
• • Breast feeding
• • Kidney failure, i.e. calculated creatinine clearance below 40 ml/min
• • Age \< 18 years
• • No signed informed consent