TEREPINS: Testosterone Replacement in Non-alcoholic Steatohepatitis

• Research type

  Research Study

• Full title

  Pilot open study of testosterone replacement in non-alcoholic steatohepatitis

• IRAS ID

  90143

• Contact name

  Dermot Gleeson

• Sponsor organisation

  Sheffield Teaching Hospitals

• Eudract number

  2012-002564-27

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  20-35% of adults have non-alcoholic fatty liver disease (NAFLD), which often leads to liver inflammation and damage and sometimes to cirrhosis, liver failure and liver cancer; it is now a common indication for liver transplantation in the UK. No medical treatment has been shown to be effective in preventing its progression. Some men with NAFLD have low serum levels of testosterone (male hormone). Often, levels are only slightly low and do not cause symptoms. However there are several reasons to think that these low levels may be aggravating the liver disease. NAFLD is thought to be caused by resistance of tissues to the actions of the hormone insulin (Insulin Resistance or IR). Low testosterone levels may cause IR. Treatments for prostatic cancer which lower testosterone levels result in both IR and in NAFLD. Mice who cannot produce testosterone also develop NAFLD and this is reversed by testosterone replacement. We therefore speculate that testosterone replacement in men with NAFLD and low blood testosterone levels will reduce liver fat. We will study 10 men with NAFLD and some inflammation or scarring (proven on liver biopsy performed for clinical diagnosis) and who have mildly reduced testosterone levels. We will see if giving a 12 month course of Testosterone Replacement Therapy (TRT) to these men will lessen the severity of their liver damage. Consented patients will be seen after 6, 18, 30, 42 and 52 weeks. They will undergo a baseline clinical assessment, blood tests, an ultra sound scan, magnetic resonance scanning of the liver (to estimate liver fat), and a repeat liver biopsy to end the study. Subjects will complete questionnaires, and undergo clinical assessment, blood tests, an ultrasound scan, and magnetic resonance (MR) scanning of the liver (to estimate liver fat) at baseline. They will have clinical assessments and blood tests at 6-weekly intervals for 12 months, when they will have a repeat liver biopsy, ultrasound and MR scan.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  12/YH/0552

• Date of REC Opinion

  4 Jan 2013

• REC opinion

  Further Information Favourable Opinion