Trial and Reference Sites

Ongoing studies using the Gentian cystatin C immunoassay.

Updated March 11, 2009

The 2nd FIELD study (Australia 2008)

Gentian is the supplier of cystatin C tests to the new follow-up FIELD study. The initial FIELD study was one of the largest and most important trials on diabetics and involved 9795 patients in Australia, New Zealand and Finland. The results were published in the prestigious medical journal The Lancet in 2006.

The FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) study was conducted to determine whether early intervention with fenofibrate could prevent cardiovascular events in patients with type 2 diabetes. FIELD is the largest prospective study examining the effects of a cholesterol-lowering medication on cardiovascular outcomes in an exclusively diabetic population. Patients with type 2 diabetes are at three to four-fold risk for developing cardiovascular disease versus people without diabetes.

14,000 cystatin C tests will be delivered to the new FIELD study. Cystatin C is the marker of choice for measuring renal function (GFR), and reduced GFR is an important factor in life-style diseases including diabetes and obesity. Newer research indicates that reduced GFR is also a good indicator of pending cardiovascular problems in an aging population.

Peace Study (Norway 2008)

A cardiovascular study at the new University of Oslo Medical Hospital (Akershus Universitetssykehus). Gentian has supplied 6,000 cystatin C tests. The study starts in the autumn of 2008.

Tromsø VI (Norway 2007)

The latest Tromsø investigation is the 6th in a comprehensive long-term health study started in 1974. From the 152,000 inhabitants of Tromsø county in Norway, 16,000 are invited to participate in the Tromsø VI. Many of the participants from 1974 are now of pensionable age and a new generation of participants with completely different lifestyles are entering the study. This is a unique opportunity to study changes in risk factors and how this relates to sickness and death during the changes of life-style and health problems observed over the last 30 years.

The Tromsø VI investigation is participating in major international cardio-vascular studies – both GENERALE and MORGAM studies – and has applied for funding from the European Union. Gentian will supply 21,000 cystatin C tests to the study. Specifically, cystatin C is the marker of choice for measuring renal function (GFR), and reduced GFR is an important factor in life-style diseases including diabetes and obesity. Newer research indicates that reduced GFR is also a good indicator of pending cardiovascular problems in an aging population.

The cystatin C tests will be allocated as follows: 14,000 tests will be used in the Tromsø VI study; and 4,000 tests will be used to measure stored samples from participants who were involved in the Tromsø IV and Tromsø V studies. The remaining 3,000 tests will be used in routine testing outside of the Tromsø VI study.