E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients qualified for bariatric surgery |
Patiënten die in aanmerking komen voor een Roux-en-Y maagomleiding |
|
E.1.1.1 | Medical condition in easily understood language |
Patients qualified for surgery for obesity |
Patienten die in aanmerking komen voor een maagverkleining vanwege 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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068900 |
E.1.2 | Term | Bariatric surgery |
E.1.2 | System Organ Class | 100000004865 |
|
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 |
Our primary objective is to compare pre-treatment with the standard low calorie diet with pre-treatment with supplemental omega-3 fatty acids on liver volume. |
Het primaire doel is om voorbehandeling met dieetvoeding te vergelijken met voorbehandeling met omega-3 vetzuren, wij kijken daarbij naar het effect op de grootte van de lever. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are patient satisfaction about different dietary pre-treatments, the effect of omega-3 fatty acids before and after bariatric surgery on immune function, including adipose tissue macrophage function, cortisol response, erythrocyte function, and the long term effect of bariatric surgery on immune function and erythrocyte function six months after surgery. |
Ook kijken we naar de impact van een preoperatief dieet, het effect op immuunfunctie en de functie van macrofagen in vetweefsel, cortisol respons, functie van de rode bloed cel en de langer termijn effecten van bariatrische chirurgie op de immuunfunctie en rode bloedcel. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Females undergoing laparoscopic gastric bypass surgery because of morbid obesity
•Age between 18 and 60 years
•Written informed consent
•Able to fit in the MRI, weight circumference <130cm, bodyweight <220kg |
•Vrouwen die in aanmerking komen voor een laparoscopische roux-en-Y bypass operatie wegens morbide obesitas
•Leeftijd tussen 18 en 60 jaar
•Geschreven informed consent
•Buikomvang kleiner dan 130cm, gewicht minder dan 220kg |
|
E.4 | Principal exclusion criteria |
•Pregnancy
•Diabetes mellitus type 1
•Current history of inflammatory, infectious or malignant disease
•The use of anti-inflammatory drugs
•Contra-indications for the use of omega-3 fatty acids
•Underwent previous bariatric procedure |
•Zwangerschap
•Diabetes mellitus type 1
•Inflammatoire aandoeningen, infectieziekten, maligniteiten
•Gebruik van anti-inflammatoire medicatie
•Contra-indicaties voor het gebruik van omega-3 fatty acids
•Bariatrische chirurgie in de voorgeschiedenis |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Volume of the left hepatic lobe |
Volume van de linker leverkwab |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
• The ex-vivo inflammatory cytokine response in LPS stimulated whole blood cells before and after bariatric surgery, measured as:
o TNF-alpha
o IL-6
o IL-10
• The low-grade inflammatory state of adipose tissue, measured by the infiltration of macrophages, expression of Netrin-1 and Unc5b, different adopokines, cytokines, signal transduction molecules and 11β-HSD-1 in adipose tissue biopsies
• Erythrocyte deformability, measured as elongation index (EI) by the LORRCA
• Erythrocyte aggregation, measured as aggregation index (AI) by the LORRCA
• Cortisol response, measured with ACTH-stimulation test
• Serum levels of cytokines before and after bariatric surgery, measured as:
o TNF-alpha
o IL-6
o IL-10
• Serum levels of C-reactive protein, HDL-cholesterol, LDL-cholesterol, triglycerides and fasting glucose
• Weight, height and BMI
• Postoperative outcome |
• De ex-vivo inflammatoire cytokine response in LPS gestimuleerde volbloedcellen gemeten als:
o TNF-alpha
o IL-6
o IL-10
• De laaggradige inflammatoire reactie in vetweefsel
• Erythrocyt deformabiliteit
• Erythrocyt aggregatie
• Cortisol respons
• Serum levels van cytokines
o TNF-alpha
o IL-6
o IL-10
• Serum waarden van C-reactive protein, HDL-cholesterol, LDL-cholesterol, triglycerides en nuchter glucose
• BMI
• Postoperatieve uitkomst |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
4 weeks, first postoperative day and after 6 months |
4 weken, eerste dag na operatie en 6 maanden na de operatie |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
standaard voorbehandeling met dieetvoeding |
Standard pre-treatment, low calory diet |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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
|
End of trial is 6 months after surgery |
Einde van de studie is 6 maanden na de operatie |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |