Het effect van fenretinide op insulinegevoeligheid.

A randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25232

Enrollment

Registered

2012-07-02

Start date

2012-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Metabolic syndrome X Insulin resistance Fatty liver

Interventions

Fenretinide 154 mg QD for 90 days. The control group will receive a placebo.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Changes in hepatic and peripheral insulin sensitivity.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactMurat Kilicarslan

m.kilicarslan@amc.uva.nl+31 (0)20 5663507

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)