GLP1R-imaging in Post-RYGB Hypoglycemia

Rijnstate Hospital

Status

Enrolling

Conditions

Hypoglycemia Post Gastric Bypass Surgery

Obesity

Hyperinsulinemic Hypoglycemia

Treatments

Diagnostic Test: GLP-1R PET

Study type

Interventional

Funder types

Other

Identifiers

NCT05597475

NL51854.091.15

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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