No registrations found.
ID
Source
Brief title
Health condition
Obesity
Metabolic syndrome X
Insulin resistance
Fatty liver
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in hepatic and peripheral insulin sensitivity.
Secondary outcome
1. Liver steatosis;
2. Plasma retinol and RBP4 levels;
3. Subcutaneous adipose tissue: Concentrations of RBP4 and key proteins involved in insulin signaling levels;
4. Plasma HPR and its metabolites (MPR, 4-oxo-HPR) levels;
5. Resting energy expenditure (REE) and body fat composition;
6. Glucoregulatory hormones, adipokines and markers of inflammation;
7. Safety and tolerability of HPR/LXS.
Background summary
The prevalence of type 2 diabetes mellitus (T2DM) and obesity is increasing. Recent studies have provided evidence that retinol binding protein 4 (RBP4) is involved in the induction of insulin resistance (IR). Fenretinide is a synthetic retinoid found to lower RBP4 levels. Preliminary data show that it might improve insulin sensitivity, making it a potential new therapy for IR and T2DM. The aim of this study is assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjects.
Study objective
Fenretinide improves insulin sensitivity in obese, insulin resistant subjects.
Study design
Baseline, days 7, 28, 58 and 88 of treatment; 14 days after last drug administration.
Intervention
Fenretinide 154 mg QD for 90 days. The control group will receive a placebo.
Inclusion criteria
1. Post menopausal female;
2. Age 40-65 years;
3. BMI ≥ 30 kg • m-2;
4. HOMA-IR ≥ 2.7;
5. Signed informed consent.
Exclusion criteria
1. T2DM treated with medication other than metformin or sulfonylurea derivates;
2. Any medical condition except for glucose intolerance, T2DM, hypertension and secondary dyslipidemia;
3. Prolonged PTT/aPTT or thrombocytopenia;
4. Retinol levels of < 1.8 uM.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3304 |
| NTR-old | NTR3502 |
| Other | METC AMC : 12/047 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |