Observational study on newly diagnosed diabetes and its complications
Official title: Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients
Run by German Diabetes Center · NCT01055093 · Data updated 2026-11-12
This study looks at the health and lifestyle of newly diagnosed adults with diabetes to see how their condition changes over time compared to people without diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 69 Years |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | German Diabetes Center Academic / other |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | September 2005 |
| Main results expected | September 2030 |
| Study ends | September 2040 |
| Registry record updated | July 16, 2025 |
| Trial ID | NCT01055093 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-69 who have been clinically diagnosed with diabetes mellitus within the last 12 months.
✕Probably not a fit
Patients with severe comorbid conditions, such as advanced heart disease or cancer, may not benefit from this study.
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 characterize the clinical, metabolic, and immunological profiles of newly diagnosed adult patients with diabetes mellitus aged 18-69. It will monitor disease progression over time and compare the findings to a control group of glucose-tolerant individuals of similar demographics. Participants will undergo thorough examinations at baseline and follow-ups at 2, 5, and 10 years, with annual telephone contacts to gather additional data on their health status and lifestyle factors.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of diabetes and its complications, ultimately improving patient outcomes.
How similar studies have gone: Other observational studies have shown success in characterizing diabetes phenotypes and their progression, indicating that this approach is supported by prior research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of diabetes mellitus according to ADA criteria * Age 18-69 * Diabetes duration since diagnosis \< 12 months * Control cohort: proven normal glucose tolerance according to ADA criteria Exclusion Criteria: * Diabetes mellitus category 3 B-H (ADA criteria) * Pregnancy * Severe renal, liver or heart disease * malignant cancer * severe psychiatric illness or addiction * participation in an intervention trial
Where it's running
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German Diabetes Center
Düsseldorf, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Principal investigator: Michael Roden, Prof., MD — German Diabetes Center
- Study coordinator: Robert Wagner, Prof., MD
- Email: robert.wagner@ddz.de
- Phone: +49-211-3382
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.