Observational study on newly diagnosed diabetes and its complications
Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | German Diabetes Center Academic / other |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Trial ID | NCT01055093 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-69 who have been clinically diagnosed with diabetes mellitus within the last 12 months.
Not a fit: Patients with severe comorbid conditions, such as advanced heart disease or cancer, may not benefit from this study.
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 performed: Other observational studies have shown success in characterizing diabetes phenotypes and their progression, indicating that this approach is supported by prior research.
Eligibility criteria
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 this trial is running
Düsseldorf, North Rhine-Westphalia
- 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
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.