search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Het effect van fenretinide op insulinegevoeligheid.


- candidate number13093
- NTR NumberNTR3502
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jul-2012
- Secondary IDs12/047 METC AMC
- Public TitleHet effect van fenretinide op insulinegevoeligheid.
- Scientific TitleA randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects.
- ACRONYMFEN
- hypothesisFenretinide improves insulin sensitivity in obese, insulin resistant subjects.
- Healt Condition(s) or Problem(s) studiedObesity, Metabolic syndrome, Insulin resistance, Fatty liver
- Inclusion criteria1. Post menopausal female;
2. Age 40-65 years;
3. BMI ≥ 30 kg m-2;
4. HOMA-IR ≥ 2.7;
5. Signed informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2012
- planned closingdate1-apr-2014
- Target number of participants20
- InterventionsFenretinide 154 mg QD for 90 days. The control group will receive a placebo.
- Primary outcomeChanges in hepatic and peripheral insulin sensitivity.
- Secondary outcome1. 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.
- TimepointsBaseline, days 7, 28, 58 and 88 of treatment; 14 days after last drug administration.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Murat Kilicarslan
- CONTACT for SCIENTIFIC QUERIES M.J.M. Serlie
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD2-jul-2012 - 15-jul-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl