Multicenter Studies

The DZD has set up multicenter clinical studies to develop precision prevention and therapy measures, i.e. the right treatment for the right patient group at the right time (Precision Medicine). Topics include type 1 diabetes and type 2 diabetes, gestational diabetes, secondary diseases, treatment of fatty liver in diabetes and insulin resistance in the brain. The Germany-wide cooperation in the research network makes it possible to initiate such large-scale studies and recruit the necessary participants. In total, more than 5,000 test subjects have already participated in the studies, which are being conducted at up to ten study locations.

First results are already available. Studies have shown that there are different subtypes of prediabetes and diabetes. Not every subgroup has the same risk of developing diabetes or severe secondary diseases. In new studies, the DZD is now developing interventions and therapies tailored to the individual subgroups to prevent or at least delay the onset of the metabolic disease and its complications.

DZD Study Centers

Munich
Prof. Dr. Anette-Gabriele Ziegler
Helmholtz Zentrum München
Phone: 089–31874790
prevent.diabetes(at)lrz.uni-muenchen.de

Prof. Dr. Jochen Seißler
Ludwig-Maximilians-Universität
Phone: 089–4400–52288
studienzentrum-diabetes(at)med.uni-muenchen.de

Prof. Dr. Hans Hauner
Technische Universität München
Phone: 089–289 249 –16/ –25
katharina.kappo(at)tum.de

Tübingen
Prof. Dr. Andreas Fritsche, Prof. Dr. Norbert Stefan, Prof. Dr. Reiner Jumpertz-von Schwartzenberg
Tübingen University Hospital
Phone: 07071–2980687
stoffwechsel(at)med.uni-tuebingen.de

Düsseldorf
Prof. Dr. Michael Roden
German Diabetes Center
Phone: 0211–3382209
studienzentrum(at)ddz.de

Berlin/Potsdam
Prof. Dr.  Joachim Spranger, Prof. Dr. Knut Mai
Deutsches Institut für Ernährungsforschung /Charité Berlin
Tel.: 030-450 514 439
diabetes(at)charite.de
dzd(at)dife.de

Dresden
Prof. Dr. Peter Schwarz, Prof. Dr. Nikolaos Perakakis, Prof. Dr. Stefan Bornstein
Dresden University Hospital
Phone: 0351–25933250
studien(at)dzd-ev.de

Heidelberg
Prof. Dr. Julia Szendrödi
Heidelberg University Hospital
Phone: 06221 56-8606
DZD.Studien(at)med.uni-heidelberg.de

Leipzig
Prof. Dr. Michael Stumvoll, Dr. Gesine Flehmig
Leipzig University Hospital
Phone: 0341-9720728
plis(at)medizin.uni-leipzig.de
https://www.uniklinikum-leipzig.de/einrichtungen/medizinische-klinik-3/en/division-of-endokrinology

Lübeck
PD Dr. Britta Wilms
Dr. Svenja Meyhöfer
Universitätsklinikum Schleswig-Holstein
Tel.: 0451 31017827
dds(at)uksh.de

DZD Core Data Set

The partners in the German Center for Diabetes Research (DZD) have agreed on a common DZD Core Data Set (DZD CDS) for clinical parameters, which is based on international IT and terminology standards. This is a central requirement for comprehensive joint data collection and use.

The DZD Core Data Set consists of 8 modules and a total of 146 parameters that are defined interdisciplinary. There are also optional parameters that are subject-specific and can be included in data analyses depending on the research question.

The DZD basic dataset establishes definitions for the collection of diabetes-relevant clinical parameters and thus makes a valuable contribution to diabetes research and forms the basis for future progress in the treatment and prevention of this widespread disease.

FAIR criteria and update: The DZD Core Data Set was revised in 2022 according to the FAIR criteria. These criteria emphasize the importance of data that is findable, accessible, interoperable and reusable. The update ensures that the dataset meets the highest standards and fulfills current research requirements.

In 2024, the Core Data Set of the German Centers for Health Research (DZG) was integrated into the DZD Core Data Set. Basic clinical parameters are thus recorded in all DZGs according to a definition, regardless of indication.

The focus of the DZD CDS is on: prediabetes, type 1 and type 2 diabetes, adults, metabolic issues, pathophysiology of metabolism


Contact: Renate Schick, DZD Head Office

DZD Core Data Set

Dopamine Action on Metabolism Depending on Genetic Heterogenety (DAG)

Two thirds of the population are currently overweight. Excess weight causes a number of illnesses, such as diabetes and heart attack as well as joint problems.

The causes of overweight are:

  • a high-calorie and high-fat diet
  • too little exercise

In addition, the brain has a decisive influence on eating behavior and thus also on body weight. In particular, the reward system (dopaminergic system) plays a key role here. Dopamine is a neurotransmitter that can trigger a reward sensation after eating. Overweight people have a reduced reward sensation after eating. This is probably due to a decreased release of dopamine in the brain.

Our genes also influence our body weight. An important risk gene influences the reward system in the brain.

The study investigates whether this gene alters the effect of dopamine in the brain. 

Recruitment for this study has been completed.

COMBAT T2 NASH Study

This study investigates whether combination therapy with empagliflozin and semaglutide or therapy with empagliflozin alone leads to a regression of non-alcoholic steatohepatitis (NASH) and at the same time prevents the progression of liver fibrosis.

Non-alcoholic fatty liver disease (NAFLD) is a common concomitant disease of type 2 diabetes mellitus. Clinical studies have shown that diabetic patients with NAFLD have an increased risk of cardiovascular disease, chronic kidney disease and diabetic neuropathy.
NAFLD is characterized by an excessive accumulation of fat in the liver cells. In addition, patients with type 2 diabetes in particular have an increased risk of the disease progressing to non-alcoholic steatohepatitis (NASH), dynamic connective tissue remodeling of the liver tissue (fibrosis; end stage: cirrhosis) with potential liver failure, and the development of liver cell carcinoma. NASH is characterized by a build-up of excess fat in the liver, accompanied by inflammation in the liver tissue.
NASH is currently not treated with targeted drugs, but rather with lifestyle changes aimed at weight loss. However, research suggests that drugs that are effective for type 2 diabetes may also have a beneficial effect on NAFLD.
In the COMBAT T2 NASH study, the active substances empagliflozin (Jardiance®) and semaglutide (Ozempic®), which are already approved for the treatment of type 2 diabetes in Germany, will be compared with a placebo (i.e. tablets or injection liquid that contain no active substance) in order to examine their effectiveness on NASH. The study will investigate whether combination therapy with empagliflozin and semaglutide or therapy with empagliflozin alone leads to a regression of NASH and at the same time prevents the progression of liver fibrosis.
The treatment with the above-mentioned drugs supports the blood glucose control of your diabetes and could at the same time contribute to the regression or non-progression of NAFLD and other diabetes-related complications.   

Recruitment for this study has been completed.

Test Triangle Study

The "Test-Triangle" study examines whether the use of the "Triangle" smartphone app helps women after having had gestational diabetes to better integrate a healthy lifestyle into their daily lives.
The study is aimed at women who have been diagnosed with gestational diabetes during a recent pregnancy. This metabolic disorder is associated with an increased risk of developing  type 2 diabetes later on. However, the right lifestyle can significantly reduce this risk. Unfortunately, young mothers have little time for their own health. For this reason, the "Triangle" smartphone app was specifically  developed for this group. The app provides support to help lead a healthy lifestyle in the areas of exercise, nutrition and stress reduction. Users of the app are mentored by a qualified online coach who takes their individual needs into account and who adapts the content of the app accordingly. With the help of the app, more healthy habits can be incorporated into the everyday life of the participants step-by-step over a period of 6 months.

Recruitment for this study has been completed.

Study information for Test Triangle at the German Register of Clinical Studies.

Prediabetes Lifestyle Intervention Study (PLIS, FollowUp)

Conventional lifestyle intervention is not sufficient to prevent type 2 diabetes in all people with prediabetes. Only individually tailored prevention can be effective here. In the completed multicenter Prediabetes Lifestyle Intervention Study (PLIS), the DZD set itself the goal of developing such personalized preventive measures. After extensive phenotyping, the PLIS study participants underwent different lifestyle programs with nutritional counseling and supervised physical activity. 1,145 patients were recruited for the PLIS study. To scientifically follow up this valuable cohort, the follow-up of the study participants was extended to a long-term observation over a period of 12 years after the intervention. Cluster analyses of the PLIS study identified first subtypes of prediabetes that have a particularly high risk of secondary diseases.

Recruitment for the study is now completed.

ClinicalTrials.gov

Study protocol

DZD Prediabetes Cohort

Prediabetes is the precursor stage of diabetes in which the blood glucose levels are already abnormal. In order to develop personalized prevention strategies for type 2 diabetes, the DZD, based on previous studies, formed a unique prediabetes cohort that is unique in Germany with 8,106 participants who are continuously being investigated. In these patients, the blood glucose concentrations of the oral glucose tolerance test were abnormal at the time of enrollment in the study, but no diabetes was present. The current data analysis showed that a family history of diabetes can already increase the risk of prediabetes by 40 percent. The participants will be monitored in follow-up studies.

EMLIFA Study

The study has shown that the diabetes drug empagliflozin, an SGLT-2 inhibitor, can significantly reduce liver fat levels in patients.

The study has been completed.

Contact

Prof. Dr. Andreas Birkenfeld
IDM


Prof. Dr. Michael Roden
DDZ


Contact Study Participation

Renate Schick
Project manager
Tel.: +49 (0)89-3187-2832
studien(at)dzd-ev.de

If you are interested in participating in diabetes studies, you can also register directly and without obligation in the register of interested parties at the national diabetes information service diabinfo.de.