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News

First Joint Clinical Trial of the DZD Is Published

In the current issue of Lancet Diabetes & Endocrinology, scientists of the German Center for Diabetes Research (DZD) and the University Hospital of Vienna led by Professor Dr. Norbert Stefan have published their results of a joint clinical trial on the treatment of non-alcoholic fatty liver disease**. By inhibiting the enzyme 11-β-hydroxysteroid-dehydrogenase 1 (11-βHSD1), the research group was able to present a successful new treatment approach.

 

Non-alcoholic fatty liver disease has become a global epidemic. In Germany, about a third of the adult population already has a fatty liver. This is not only problematic in terms of the possible progression of the disease towards cirrhosis and liver cancer, but also because of the high risk of developing type 2 diabetes and cardiovascular diseases.
In recent years research has increasingly been conducted throughout the world on the causes of fatty liver and the treatment options for this disease. Scientists of the University Hospital Tübingen, Medical Department IV were able to show in the TULIP study (Tübingen Lifestyle Intervention Program) that a structured lifestyle intervention in the treatment of fatty liver disease is very successful. They also showed that not every person benefits in the same measure from such an intervention***. Therefore, researchers have increased their efforts to find new drug approaches, and thus a clinical trial was carried out.
With the aid of a drug that is currently under development to inhibit the enzyme 11-βHSD1, which produces cortisol from the inactive precursor cortisone, researchers attempted to reduce the fat content of the liver. After administering the drug for three months, the fat content in the liver was reduced in comparison to a placebo. In 20 percent of the trial subjects, the fatty liver could even be resolved. Patients who received the new drug showed a decrease in the elevated liver enzymes. They lost a significant amount of weight and in particular showed a reduction of the unfavorable abdominal fat.
“These new findings are a first step to provide people who do not sufficiently benefit from a lifestyle intervention for the treatment of fatty liver disease with another treatment option. Perhaps this new therapy concept will also become increasingly important in the future for the treatment of obesity,” said Prof. Norbert Stefan, who led the clinical trial.
Under the auspices of the German Center for Diabetes Research (DZD), scientists of the Medical Department IV of University Hospital Tübingen, the German Diabetes Center Düsseldorf, the German Institute of Human Nutrition Potsdam-Rehbrücke, the Medical Clinic of the University of Vienna and the pharmaceutical company Hoffmann-La Roche were involved in the trial on people with fatty liver disease.

Further trials in cooperation with the participating institutions, particularly with the DZD, are planned.


Audio Interview
with Prof. Stefan from February 17, 2014 is available at http://www.thelancet.com/landia-audio/


Titles of the Publications
**Stefan N, Ramsauer M, Jordan P, Nowotny B, Kantartzis K, Machann J, Hwang JH, Nowotny P, Kahl S, Harreiter J, Hornemann S, Sanyal AJ, Stewart PM, Pfeiffer AF, Kautzky-Willer A, Roden M, Häring HU, Fürst-Recktenwald S. Inhibition of 11β-HSD1 with RO5093151 for non-alcoholic fatty liver disease: a multicentre, randomised, double-blind, placebo-controlled trial. The Lancet Diabetes & Endocrinology (2014). 2:406-416. doi:10.1016/S2213-8587(13)70170-0


***Kantartzis K, Thamer C, Peter A, Machann J, Schick F, Schraml C, Königsrainer A, Königsrainer I, Kröber S, Niess A, Fritsche A, Häring HU, Stefan N. High cardiorespiratory fitness is an independent predictor of the reduction in liver fat during a lifestyle intervention in non-alcoholic fatty liver disease. Gut. 2009 Sep;58(9):1281-8. doi: 10.1136/gut.2008.151977.

***Kantartzis K, Thamer C, Peter A, Machann J, Schick F, Schraml C, Königsrainer A, Königsrainer I, Kröber S, Niess A, Fritsche A, Häring HU, Stefan N. High cardiorespiratory fitness is an independent predictor of the reduction in liver fat during a lifestyle intervention in non-alcoholic fatty liver disease. Gut. 2009 Sep;58(9):1281-8. doi: 10.1136/gut.2008.151977.