Observational study on diabetes and its complications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to monitor the presence and development of complications in patients with type 1 and type 2 diabetes, as well as pre-diabetics. It seeks to identify new metabolic mechanisms and risk factors associated with diabetic complications by enrolling non-diabetic controls for comparison. The study will analyze data from participants aged 18 to 75 years who meet specific diagnostic criteria for diabetes or pre-diabetes, without any planned interventions. The goal is to better understand the complexities of diabetes and its related health issues.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Medicine, University of Heidelberg
  Heidelberg, Germany Recruiting

Study contacts

• Principal investigator: Stefan Kopf, MD — Head of the Clinical Study Center for Diabetes Research
• Study coordinator: Stefan Kopf, MD
• Email: stefan.kopf@med.uni-heidelberg.de
• Phone: +49-6221-56

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Digital twins to classify mental health patterns in adults with diabetes

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• Thai PainPREDICT for detecting neuropathic pain in people with diabetes

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• Factors linked to diabetic foot ulcer severity and outcomes

  This project looks at records of about 200 people with diabetic foot ulcers treated at 5 Azar Hospital in 2024 to see if blood tests and other health factors link to worse ulcers.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.