The effects of fenretinide on insulin sensitivity
Active, not recruiting
- Conditions
- ObesityMetabolic syndrome XInsulin resistanceFatty liverTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-006165-18-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Liver steatosis<br>Plasma retinol and RBP4 levels<br>Plasma HPR and its metabolites (MPR, 4-oxo-HPR) levels<br>Resting energy expenditure (REE) and body fat composition<br>Glucoregulatory hormones, adipokines and markers of inflammation<br>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