Visualizing beta cells in patients with postprandial hyperinsulinemic hypoglycemia after bariatric surgery

Conditions: Hyperinsulinaemic hypoglycaemia after Roux-en-Y gastric bypass surgery
MedDRA version: 18.0Level: LLTClassification code 10059035Term: Postprandial hypoglycaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 18.0Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 18.0Level: PTClassification code 10060378Term: HyperinsulinaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2014-005554-20-NL

Lead Sponsor: Radboud University Medical Center Nijmegen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 24

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- determine the correlation between measured 68Ga-exendin accumulation and beta cell function and<br>- 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 Outcome Measures

Name	Time	Method
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.<br>;Timepoint(s) of evaluation of this end point: 1 hour after injection of the radiotracer the PET scan is performed.