Hyperinsulinaemic hypoglycaemia after Roux-en-Y gastric bypass surgery MedDRA version: 18.0 Level: LLT Classification code 10059035 Term: Postprandial hypoglycaemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 18.0 Level: HLGT Classification code 10018424 Term: Glucose metabolism disorders (incl diabetes mellitus) System Organ Class: 10014698 - Endocrine disorders MedDRA version: 18.0 Level: PT Classification code 10060378 Term: Hyperinsulinaemia System Or
Conditions
Sponsors
Radboud University Medical Center Nijmegen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HH group - Signed informed consent - >18 - Persisting hyperinsulinemic hypoglycemia after a low-carbohydrate diet and/or insulin suppressive medication for one year. Control group - Signed informed consent - >18 - RYGB at least 2 years ago - Normal glucose levels before and after RYGB (fasting glucose between 4 and 6 mmol/l and/or HbA1c between 20 and 42 mmol/mol) - Individual matched to HH group on age (± 5 years), sex and BMI at time of inclusion (± 2 kg/m2) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: HH group - Anti-diabetic medication in the past 6 months - Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors - Known liver failure or serum liver values over 2 times the normal values. - 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 Additional exclusion for controle group - Any diabetic history (e.g. including diabetes during pregnancy) - Previous diagnosed HH or hypoglycemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to examine if 68Ga-exendin tracer accumulation (i.e. beta cell mass) differs in patients with persisting HH after RYGB compared to matched patients without HH after RYGB. ;Secondary Objective: The secondary objectives are: - determine the correlation between measured 68Ga-exendin accumulation and beta cell function and - evaluate if a (focal) increase in beta cell mass is the underlying cause of HH in a part of the patients with persisting HH.;Primary end point(s): The main parameter of the study is the quantitative assessment of pancreatic 68Ga-NODAGA-exendin-4 uptake in patients suffering from persisting HH after RYGB and matched controls.;Timepoint(s) of evaluation of this end point: 1 hour after injection of the radiotracer the PET scan is performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are the pancreatic distribution of 68Ga-exendin-4 as assessed by experts from the nuclear medicine department and the correlation between pancreatic 68Ga-exendin-4 uptake and beta cell function. ;Timepoint(s) of evaluation of this end point: 1 hour after injection of the radiotracer the PET scan is performed. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of surgery
Rijnstate hospital
Outcome results
None listed