Effect of PNPLA3, TM6SF2 and MBOAT7 Genetic Variants on Non-alcoholic Fatty Liver Disease Therapeutic Outcome.

• Status: Completed
• Trial end date: 2018-04-17
• Target enrollment: 0
• Participant gender: All

Summary

Patatin-like phospholipase domain-containing protein-3 (PNPLA3), the transmembrane 6 superfamily member 2 protein (TM6SF2) and membrane bound O-acyltransferase domain containing 7 (MBOAT7) genes are involved in non-alcoholic fatty liver disease (NAFLD) development and worsening. Following the actual scientific knowledge, some studies have identified the genetic background surrounding NAFLD, counting up to forty different genetic variants that seem to exert also a crucial role in the disease evolution, according to the natural history, until hepatocellular carcinoma onset. However, few data exist regarding their influence on the treatment response. The aim was to explore the effect of 303 mg of silybin-phospholipids complex, 10 mg of vitamin-D and 15 mg of vitamin-E twice a day for six months in NAFLD patients carrying PNPLA3-rs738409, TM6SF2-rs58542926 and MBOAT7-rs641738 genetic variants. The assessed mutations are independently associated with no response to a silybin/vitamin D-based therapy and could be useful therapeutic predictive markers in this context.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Campania "Luigi Vanvitelli"
• Collaborators: Federico II University; University of Salerno
• Treatments: Silybin; Vitamin D; Vitamin E; Vitamins

Criteria

Inclusion criteria

• age between 18 and 80 years

• diagnosis of NAFLD

Exclusion criteria

• diagnosis of chronic inflammatory disease such as inflammatory bowel disease, rheumatoid arthritis, acute or chronic kidney disease, systemic lupus erythematosus, or other major inflammatory systemic diseases

• diagnosis of insulin dependent diabetes

• diagnosis of tumors

• diagnosis of ongoing infections

• alcohol or drug abuse medical history

• diagnosis of other etiologies of chronic liver damage

• use of hepatoprotective drugs

• psychological/psychiatric problems that could invalidate the informed consent