Obesity Metabolic syndrome X Insulin resistance Fatty liver
Conditions
Interventions
Product Name: fenretinide/Lym-X-Sorb
Product Code: HPR/LXS
Pharmaceutical Form: Oral powder
INN or Proposed INN: FENRETINIDE
CAS Number: 65646-68-6
Concentration unit: IU/mg international unit(s)/mill
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-65 years BMI = 30 kg • m-2 HOMA-IR = 2.7 Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the effects of fenretinide on hepatic steatosis, body weight and body fat composition;Main Objective: To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjects;Primary end point(s): Changes in hepatic and peripheral insulin sensitivity;Timepoint(s) of evaluation of this end point: Baseline and day 88 of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: Baseline, days 7, 28, 58 and 88 of treatment; 14 days after last drug administration | — |
Countries
Netherlands
Contacts
Public ContactMireille Serlie
Academic Medical Center
Outcome results
None listed