E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hyperinsulinaemic hypoglycaemia after Roux-en-Y gastric bypass surgery |
Hyperinsulinaemische hypoglycaemie na Roux-en-Y gastric bypass chirurgie |
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E.1.1.1 | Medical condition in easily understood language |
Hyperinsulinaemic hypoglycaemia after Roux-en-Y gastric bypass surgery |
Hyperinsulinaemische hypoglycaemie na Roux-en-Y gastric bypass chirurgie |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059035 |
E.1.2 | Term | Postprandial hypoglycaemia |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10018424 |
E.1.2 | Term | Glucose metabolism disorders (incl diabetes mellitus) |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060378 |
E.1.2 | Term | Hyperinsulinaemia |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Het primaire doel van dit onderzoek is om de opname van 68Ga-exendin-4 in de pancreas te bepalen bij patiënten die een RYGB hebben ondergaan en wel en geen HH hebben te vergelijken middels een PET beelden. |
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E.2.2 | Secondary objectives of the trial |
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. |
De secondaire doelen zijn:
- de relatie bepalen tussen de gemeten 68Ga-exendin stapeling in de pancreas en de beta cel functie.
- onderzoeken of een (focale) toename van beta cel massa de mogelijke oorzaak kan zijn van HH in een deel van de patientengroep. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
HH groep
- Getekende informed consent
- > 18 jaar
- Persisterende hyperinsulinemische hypoglycaeamia na therapie met een koolhydraatarm dieet en/of insuline verlagende medicatie
Controle groep
- Getekende informed consent
- > 18 jaar
- RYGB minimaal 2 jaar geleden ondergaan
- Normale glucosewaarden voor en na de gastric bypass operatie (RYGB) (nuchtere glucose tussen 4 en 6 mmol/l en/of HbA1c tussen 20 en 42 mmol/mol)
- Individueel gematcht met HH groep voor leeftij (± 5 jaar), geslacht en BMI op moment van inclusie (± 2 kg/m2)
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E.4 | Principal 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 |
HH group
- Anti-diabetische medicatie gebruikt in de afgelopen 6 maanden
- Eerdere behandeling met synthetische Exendin (Exenatide, Byetta®) of een Dipeptidyl-Peptidase IV inhibitor
- Bekendeleverfalen of serum lever waarden meer dan 2 keer de normale waarden.
- Zwanger, of de wens om zwanger te worden in de komende 6 maanden.
- Borst voeding
- Nierfalen, ofwel een creatinine klaring lager dan 40 ml/min
- Jonger dam 18
- Geen getekende informed consent
Additionele exclusie criteria voor controle groep
- Enige diabetische geschiedenis (inclusief zwangerschapsdiabetes)
- Eerder gediagnosticeerde HH of hypoglycemie |
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E.5 End points |
E.5.1 | 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. |
De primaire parameter in deze studie is de kwantitatieve bepaling van de opname van 68Ga-exendin-4 in de pancreas bij post-RYGB patiënten met en zonder HH middels PET-CT beelden. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 hour after injection of the radiotracer the PET scan is performed. |
1 uur na het toedienen van de radiotracer wordt de PET scan gemaakt. |
|
E.5.2 | 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.
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Secundaire variabelen zijn de verdeling van 68Ga-exendin-4 in de pancreas en de correlatie tussen de opname van 68Ga-exendin-4 in de pancreas en de beta cel functie bij post-RYGB patiënten met en zonder HH middels PET-CT beelden. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 hour after injection of the radiotracer the PET scan is performed. |
1 uur na het toedienen van de radiotracer wordt de PET scan gemaakt. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |