NCT03022721 Heidelberg Study on Diabetes and Complications
| NCT ID | NCT03022721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heidelberg University |
| Condition | Diabetes Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2016-09 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2016-09 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The prospective observational study entitled "Heidelberg Study on Diabetes and Complications" is designed to Monitor the presence and development of diabetic complications in type 1 and type 2 diabetic patients, as well as pre-diabetics. Mail Goal is to detect new metabolic mechanisms or new risk factors for the development of diabetic complications in order to identify risk-subgroups. Non-diabetic controls will be enrolled for reference and comparison.
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
Contact & Investigator
Stefan Kopf, MD
PRINCIPAL INVESTIGATOR
Head of the Clinical Study Center for Diabetes Research
Frequently Asked Questions
Who can join the NCT03022721 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Diabetes Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03022721 currently recruiting?
Yes, NCT03022721 is actively recruiting participants. Contact the research team at stefan.kopf@med.uni-heidelberg.de for enrollment information.
Where is the NCT03022721 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT03022721 clinical trial?
NCT03022721 is sponsored by Heidelberg University. The principal investigator is Stefan Kopf, MD at Head of the Clinical Study Center for Diabetes Research. The trial plans to enroll 500 participants.
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