E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obesity
Metabolic syndrome X
Insulin resistance
Fatty liver |
Obesitas
Metabool syndroom
Insulineresistentie
Leversteatose |
|
E.1.1.1 | Medical condition in easily understood language |
Obesity
Insulin resistance
Fatty liver disease |
Ernstig overgewicht
Insulineongevoeligheid
Leververvetting |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
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 |
To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjects |
Vaststellen van het effect van fenretinide op hepatische en perifere insulinegevoeligheid in obese, insulineresistente proefpersonen |
|
E.2.2 | Secondary objectives of the trial |
To assess the effects of fenretinide on hepatic steatosis, body weight and body fat composition |
Vaststellen van het effect van fenretinide op leversteatose, lichaamsgewicht en lichaamsvetcompositie |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18-65 years
BMI ≥ 30 kg • m-2
HOMA-IR ≥ 2.7
Signed informed consent |
Leeftijd tussen 18-65 jaar
BMI ≥ 30 kg • m-2
HOMA-IR ≥ 2.7
Getekend informed consent |
|
E.4 | Principal exclusion criteria |
T2DM treated with medication other than metformin or sulfonylurea derivates
Any medical condition except for glucose intolerance, T2DM, hypertension and secondary dyslipidemia
Retinol levels of < 1.8 uM
Pregnant, lactating or planning pregnancy during the treatment |
Diabetes mellitus type 2 (DM2) behandeld met medicatie anders dan metformine of sulfonylureumderivaten
Alle medische condities behoudens glucoseintolerantie, DM2, hypertensie en secundaire dyslipidemie
Retinolconcentratie < 1.8 uM
Zwanger, lacterend of zwangerschapswens tijdens de studie |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Changes in hepatic and peripheral insulin sensitivity |
Veranderingen in hepatische en perifere insulinegevoeligheid |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and day 88 of treatment |
Baseline en dag 88 van behandeling |
|
E.5.2 | Secondary end point(s) |
Liver steatosis
Plasma retinol and RBP4 levels
Plasma HPR and its metabolites (MPR, 4-oxo-HPR) levels
Resting energy expenditure (REE) and body fat composition
Glucoregulatory hormones, adipokines and markers of inflammation
Safety and tolerability of HPR/LXS |
Leversteatose
Retinol- en RBP4-waarden
HPR- en zijn metabolieten (MPR, 4-oxo-HPR)-waarden
Energieverbruik in rust (REE) en lichaamsvetcompositie
Glucoregulerende hormonen, adipokines en inflammatiemarkers
Veiligheid en tolerabiliteit van HPR/LXS |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, days 7, 28, 58 and 88 of treatment; 14 days after last drug administration |
Baseline, dag 7, 28, 58 en 88 van behandeling; 14 dagen na laatste inname |
|
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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
LVLS |
Laatste visite laatste proefpersoon |
|
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 | 0 |