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Heidelberg Study on Diabetes and Complications

Launched by HEIDELBERG UNIVERSITY · Jan 12, 2017

Trial Information

Current as of July 07, 2025

Recruiting

Keywords

ClinConnect Summary

The Heidelberg Study on Diabetes and Complications is a research project aimed at understanding how diabetes can lead to various health issues over time. The study will closely monitor people with type 1 and type 2 diabetes, as well as those who are pre-diabetic, to identify new factors that might increase the risk of complications from diabetes. By also including healthy individuals without diabetes, researchers hope to gain a clearer picture of what contributes to these complications.

To participate, individuals need to be between 18 and 75 years old and have a confirmed diagnosis of diabetes or pre-diabetes based on specific blood sugar levels. Participants can expect to undergo various tests and assessments to help researchers gather important information about their health. However, certain conditions, like severe heart or kidney issues, or recent cancer treatments, may prevent someone from joining the study. This research is crucial for finding ways to better manage diabetes and reduce the risk of complications in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria Age between 18 and 75 years Persons with manifest diabetes mellitus type 1 or type 2 and diagnosis according to DDG guidelines 2011, that is HbA1c of 6,5 percent or higher after exclusion of false values, more than 200 mg per dl two hours after glucose in the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice Healthy persons without diabetes or impairment of glucose metabolism in the oGTT according to DDG guidelines 2011 fasting plasma glucose less than 100 mg per dl and 2 hour plasma glucose less than 140 mg per dl Pre diabetics with impaired fasting glucose between 100 mg per dl and 125 mg per dl, or impaired glucose tolerance with 2 hour glucose values between 140 and 199 mg per dl in the oGTT, all values from venous plasma
  • Exclusion Criteria General exclusion criteria Secondary types of Diabetes, ADA criteria type 3 B H Current pregnancy Acute infections or fever Immune suppressant therapy Severe psychiatric diseases requiring treatment, including personality disorders, schizophrenia, depression Known alcohol or drug dependency Severe heart NYHA stadium IV, kidney, or liver insufficiency Non diabetic liver disease, for example PBC, PSC, Wilsons disease, hemochromatosis, autoimmune hepatitis severe peripheral artery disease stadium IV non diabetic glomerulopathy Cancer or other malignant diseases within the last 5 years Infectious diseases like hepatitis B, C, E, or HIV Other severe autoimmune diseases Current participation in an interventional study Anemia or disorders of bone marrow Exclusion criteria for MRI Pacemaker or ICD Metallic and magnetic implants, for example mechanic cardiac valves replacements, joint prostheses, clips after vascular surgery, middle or inner ear implants, recent tooth implants, penile implants Waist circumference more than 135 cm Claustrophobia Allergies against MRI contrast Impaired kidney function with a GFR less than 65 ml per min
  • Exclusion criteria for clamp study Past history of deep vein thrombosis or pulmonary embolism Routine laboratory test results less than 80 percent below lower reference value of Ferritin, iron, leucocytes, hemoglobin, hematocrite, RBC, platelets, blood alcohol Level
  • Exclusion criteria for bioimpedance measurement Pacemaker or ICD
  • Exclusion criteria for lung function testing Ignoring or non understanding of the instructions Body weight more than 160 kg

About Heidelberg University

Heidelberg University, a prestigious institution located in Germany, is renowned for its commitment to advancing medical research and clinical innovation. With a strong emphasis on interdisciplinary collaboration, the university fosters a dynamic environment for conducting clinical trials that aim to enhance patient care and improve health outcomes. Leveraging cutting-edge technology and a robust network of healthcare professionals, Heidelberg University is dedicated to exploring novel therapeutic approaches and contributing to the global medical community through rigorous scientific inquiry and ethical research practices.

Locations

Heidelberg, , Germany

Patients applied

0 patients applied

Trial Officials

Stefan Kopf, MD

Principal Investigator

Head of the Clinical Study Center for Diabetes Research

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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