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

Recruiting

Conditions: 10018424
10017998
hyperinsulinemic hypoglycaemia
low blood glucose caused by excessive insulin

Registration Number: NL-OMON44909

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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.;Controle 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)
- Score <= 7 on Sigstad's scoring system
- 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

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
-Sigstad*s dumping score > 7

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main parameter of the study is the quantitative assessment of pancreatic<br /><br>68Ga-NODAGA-exendin-4 uptake in patients suffering from persisting HH after<br /><br>RYGB and matched controls. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the GLP1 and GIP responses after the MMT, the<br /><br>pancreatic distribution of 68Ga-exendin-4 as assessed by experts from the<br /><br>nuclear medicine department and the correlation between pancreatic<br /><br>68Ga-exendin-4 uptake and beta cell function. </p><br>