New Unit for DZD Diabetes Clinical Trials at Heidelberg University Hospital

A new unit for diabetes clinical trials at Heidelberg University Hospital shall help to elucidate the pathogenesis and course of diabetes mellitus and its complications. Within the framework of long-term trials, physicians shall examine patients who have various stages of the disease (pre-diabetes, newly diagnosed diabetes, long standing diabetes) with regard to possible long-term damage such as heart attacks, strokes, blindness and nerve disorders. Until now the consensus was that maintaining good blood glucose control reduces these complications. However, studies could not confirm this. Therefore, the researchers want to elucidate which metabolic processes cause these late complications.

Participants are still needed for three major trials. They should be at least 18 years old; a referral is not necessary. Participants will be given a comprehensive clinical examination and medical counseling and will receive an allowance to cover expenses. The patient’s primary physician will receive a detailed report of the findings.

Diabetes mellitus still not adequately understood
“Our understanding of diabetes mellitus is still not adequate,” said Dr. Stefan Kopf, senior physician at the Department of Endocrinology, Metabolism and Clinical Chemistry. As head of the Unit for Diabetes Clinical Trials, which collaborates with the German Center for Diabetes Research (DZD) and the German Diabetes Center (DDZ) in Düsseldorf, he explained that the problem lies in the dogmatization of the surrogate parameter HbA1c. Surrogate parameters are laboratory values that only provide an indirect inference to the metabolic processes, but have no direct connection with the actual disease. This HbA1c value is used in medical practice to monitor the course of the diabetes mellitus and to coordinate the treatment on the basis of this value.
The first results of large clinical trials in the late 1970s indicated that high blood glucose levels and a high HbA1c value were detrimental for the patients concerned and thus required treatment. Follow-up studies, however, showed that blood glucose levels or the HbA1c value only explained about 11 percent of all long-term damage. Another trial, in which blood glucose levels were aggressively reduced, had to be canceled because a number of patients died.
“Typical late complications of diabetes arise even if blood glucose levels are not elevated – this has been shown by further results from basic research. Diabetes should therefore not only be defined by elevated blood glucose levels. Here special molecules – so-called reactive metabolites – play a role that intervene in various metabolic mechanisms and therefore lead to long-term damage,” said Dr. Stefan Kopf. 

Participants are currently being sought for the following trials:
 Pre-Diabetes Intervention Study (PLIS)
 Patients with pre-diabetes may participate in this trial – i.e. patients who are overweight and have elevated blood glucose levels between 100-125 mg/dl. The lifestyle intervention study includes a detailed clinical examination, an MRI to monitor the success of the intervention as well as nutrition and exercise counseling. The trial is designed for a period of three years with the aim of preventing the onset of manifest diabetes.
 German Diabetes Study (DDS)
Patients with newly diagnosed diabetes mellitus (type 1 and 2) may participate in this study. The study duration is ten years. Patients receive both a detailed clinical examination and an MRI. The aim of this study is to better understand the development of diabetes and its late complications.
 Gestational Diabetes Study (PREG)
This trial is for the early detection of gestational diabetes. In addition, the individual risk for developing type 2 diabetes after pregnancy shall be investigated. The minimum observation period is one year.
Depending on the trial, an expense allowance between 25 and 400 EUR shall be paid to the participants.

Interested patients can apply directly to the Unit for Diabetes Clinical Trials Heidelberg:
Phone: +49(0)6221 56 - 8606 or 56 – 36323

University Hospital and Medical School of Heidelberg: patient care, research and teaching of high international reputation
 Heidelberg University Hospital is one of the leading medical centers in Germany; the Medical School of the University of Heidelberg is among the top internationally renowned biomedical research institutions in Europe. The common goal is to develop innovative diagnostics and treatments and to implement them quickly to benefit patients. The Hospital and the Medical School employ around 12,600 employees and are active in training and qualification programs. Each year, around 66,000 patients receive full or partial inpatient care in more than 50 clinical departments (circa 1,900 beds), and more than one million outpatient consultations are provided. The Heidelberg Curriculum Medicinale (HeiCuMed) is considered to be one of the top medical training programs in Germany. At present, approximately 3,500 aspiring doctors are studying in Heidelberg.

Further information:
Unit for Diabetes Clinical Trials Heidelberg