E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Type 2, bariatric surgery, morbid obesitas |
Diabetes Type 2, bariatricsche chirurgie, morbide obesitas |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetes Type 2, bariatric surgery, morbid obesitas |
Diabetes Type 2, bariatricsche chirurgie, morbide obesitas |
|
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 | 19.0 |
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 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012602 |
E.1.2 | Term | Diabetes mellitus (incl subtypes) |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
|
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 the change in 68Ga-exendin tracer accumulation in the pancreas (i.e. beta cell mass) after RYGB by quantitative analysis of PET images before and one year after RYGB in morbid obese patients with type 2 diabetes. |
Het primaire doel is om het verschil in 68Ga-exendin tracer stapeling in de pancreas te bepalen tussen voor en na RYGB in morbide obese patienten met T2D, middels kwantitatieve PET beelden. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are: - Examine if pre-operative pancreatic 68Ga-exendin accumulation has a prognostic value for T2D resolution in morbid obese patients with T2D. - Determine the correlation between pre- and post-RYGB beta cell function and insulin resistance and 68Ga-exendin tracer accumulation in the pancreas.
|
Secundaire doelen zijn: - Onderzoeken of de pre-operatieve stapeling van 68Ga-exendin in de pancreas een prognostische waarde heeft voor T2D resolutie na RYGB. - De correlatie bepalen tussen 68Ga-exendin stapeling in de pancreas en beta cel functie en insuline resistance. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Morbid obese T2D patient who will undergone RYGB at the Rijnstate in Arnhem (BMI > 35 kg/m2) - Female - Signed informed consent
Mild T2D group o C-peptide > 1.3 nmol/l o T2D diagnosis < 2 years before RYGB o Only metformin usage as anti-diabetic medication
Severe T2D group o C-peptide < 1 nmol/l o T2D diagnosis > 4 years before RYGB o Insulin and/or sulfonylurea (SU) usage
|
- Morbide obese T2D patienten die een RYGB zullen ondergaan in het Rijnstate in Arnhem (BMI > 35 kg/m2) - Vrouw - Getekende informed consent
Milde T2D groep o C-peptide > 1.3 nmol/l o T2D diagnose < 2 jaar voor RYGB o Alleen metformine gebruik als anti-diabetische medicatie
Ernstige T2D groep o C-peptide < 1 nmol/l o T2D diagnose> 4 jaar voor o Insulinea en/of sulfonylurea (SU) gebruik
|
|
E.4 | Principal exclusion criteria |
- Fasting glucose < 7 mmol/l at time C-peptide was determined (Aarts et al. 2013) - Known liver failure or serum liver values over 2 times normal value at the time of standard laboratory assessment. - BMI > 50 kg/m2 - Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors - Pregnancy or the wish to become pregnant within 18 months - Breast feeding - Kidney failure, i.e. calculated creatinine clearance below 40ml/min - Age < 18 years - No signed informed consent
|
- Nuchtere glucose < 7 mmol/l op het moment dat C-peptide is bepaald (Aarts et al. 2013) - Bekende leverfalen of lever waarden meer dan 2 maal de normaal waarde - BMI > 50 kg/m2 - Eerdere behandeling met synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors - Zwanger of de wens zwanger te worden binnen 18 maanden - Borst voeding - Nierfalen, ofwel een berekende creatinine klaring < 40ml/min - < 18 years - Geen getekende informed consent
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The main study parameter is the difference in uptake of 68Ga-NODAGA-exendin-4 in the pancreas one year after a RYGB, measured by quantitative analysis of the PET images before and one year after a RYGB. Secondary endpoint is the correlation between T2D outcome and the change in pancreatic uptake of 68Ga-NODAGA-exendin-4 one year after a RYGB. |
De primaire uitkomst is de verandering van 68Ga-NODAGA-exendin-4 stapeling in de pancreas na een RYGB, bepaald middels kwantitatieve PET beelden gemaakt voor en een jaar na een RYGB |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
PET scan is performed 1 hour after injection of radiopharmacon |
PET scan wordt gemaakt 1 uur na de toediening van het radiofarmacon |
|
E.5.2 | Secondary end point(s) |
Secondary parameters are the correlation between pre-operatively measured pancreatic 68Ga-exendin uptake and T2D resolution and the correlation between pancreatic 68Ga-exendin uptake and beta cell function before and after RYGB. |
Secundaire uitkomsten zijn: - de correlatie tussen pre-operatieve gemeten stapeling van 68Ga-exendin in de pancreas en de T2D resolutie na RYGB. - de correlatie tussen gemeten stapeling van 68Ga-exendin in de pancreas en de beta cel functie en insuline resistance (voor en na RYGB) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
PET scan is performed 1 hour after injection of radiopharmacon |
PET scan wordt gemaakt 1 uur na de toediening van het radiofarmacon |
|
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 |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |