Observational study on diabetes and its complications
Heidelberg Study on Diabetes and Complications
This study looks at how diabetes and pre-diabetes affect health over time and what new risk factors might be involved, by comparing people with diabetes to those without it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Heidelberg University Academic / other |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT03022721 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with diagnosed type 1 or type 2 diabetes, pre-diabetics, or healthy individuals without glucose metabolism impairment.
Not a fit: Patients with secondary types of diabetes, current pregnancy, acute infections, or those undergoing immune suppressant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification of risk factors for diabetic complications, potentially guiding future prevention strategies.
How similar studies have performed: While many studies have focused on diabetes management, this study's unique approach to understanding the underlying mechanisms of complications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heidelberg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.