Hyperinsulinemic Hypoglycemia, Hypoglycemia Post Gastric Bypass Surgery, Obesity
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTGLP-1R PET
Beta cell function (tests) and measure for beta cell mass (PET)
Sponsors
Rijnstate Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pancreatic uptake of 68Ga-NODAGA-exendin-4 | baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beta cell function | baseline | Measured as total insulin during MTT and insulin peak during arginine test |
Countries
Netherlands
Outcome results
None listed