Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2016-11-01
2024-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Patients
Patients with hypoglycemia
GLP-1R PET
Beta cell function (tests) and measure for beta cell mass (PET)
Controls
Patients without post-bariatric hypoglycemia
GLP-1R PET
Beta cell function (tests) and measure for beta cell mass (PET)
Interventions
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GLP-1R PET
Beta cell function (tests) and measure for beta cell mass (PET)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
Yes
Sponsors
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Rijnstate Hospital
OTHER
Responsible Party
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Laura Deden
Principal Investigator
Locations
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Rijnstate hospital
Arnhem, , Netherlands
Countries
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Facility Contacts
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Other Identifiers
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NL51854.091.15
Identifier Type: -
Identifier Source: org_study_id
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