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NCT Number: NCT03658512

Tübinger Diabetes Mellitus Database (TUEDID)

Diabetes mellitus is a widespread disease with increasing prevalence worldwide. Patients with diabetes can develop multiple late complications such as neuropathy, retinopathy, nephropathy and cardiovascular comorbidities. So far, there are no reliable predictive tools or markers to estimate if, when and to what extent a patient with diabetes develops late complications. For the patients quality of life and for health economic reasons an improved risk assessment would be desirable. The prospective TUEDID study will characterize diabetic patients to look out for parameters the predict progression of diabetes and its complications.

Recruiting

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Tuebingen, Internal medicine IV

Tübingen, 72074, Germany

Location status: Recruiting

Location contact

Andreas Fritsch, Prof, MD

CONTACT

[email protected]

+49 7071 29 ext. 82711

Andreas Fritsche, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years

Exclusion criteria

  • no written informed consent

Treatment and study plan

Primary outcomes

  1. Glycemic control (blood glucose)

    Time frame: At enrolment

    Assessed as fasting blood glucose and HbA1C

  2. Glycemic control (HbA1C)

    Time frame: At enrolment

    Assessed as fasting HbA1C

Other outcomes

  1. Liver function

    Time frame: At enrolment

    Parameters for liver function will be assessed (GOT, GPT, AP, Gamma-GT, Lipase, all [U/l])

  2. Renal function

    Time frame: At enrolment

    Parameters for renal function will be assessed (Creatinine, Urea, Cystatin C, all [mg/dl])

  3. Glomerular filtration rate (GFR)

    Time frame: At enrolment

    Glomerular filtration rate will be determined [ml/min/1,73 m²]

  4. Lipid status

    Time frame: At enrolment

    Parameters for evaluation of lipid status will be assessed (LDL, HDL, Cholesterol, triglycerides, all [mg/dl])

  5. Inflammation

    Time frame: At enrolment

    Parameters to evaluate the inflammatory state will be assessed (CRP [mg/dl])

  6. Insulinemia

    Time frame: At enrolment

    Insulin and C-peptide concentrations will be assessed [pmol/l]

  7. Hormones

    Time frame: At enrolment

    Parameters for evaluation of hormonal status will be assessed (TSH [mU/l])

  8. Hormones

    Time frame: At enrolment

    Parameters for evaluation of hormonal status will be assessed (fT3 and fT4 [pmol/l])

  9. Hormones

    Time frame: At enrolment

    Parameters for evaluation of hormonal status will be assessed (Cortisol [nmol/l])

  10. Urine parameters

    Time frame: At enrolment

    Parameters from urine will be assessed (albumin, total protein, both [mg/l])

  11. Urine parameters

    Time frame: At enrolment

    Parameters from urine will be assessed (creatinine [ml/min])

  12. Urine parameters

    Time frame: At enrolment

    Parameters from urine will be assessed (urine sediment via microscopy)

  13. Pancreas

    Time frame: At enrolment

    Lipase and amlyase concentrations for evaluation of pancreas status will be assessed [U/l]

  14. Coagulation

    Time frame: At enrolment

    Parameters for evaluation of coagulation status will be assessed (INR, blood cell count)

  15. Angiological examination

    Time frame: At enrolment

    Angiological examination of parameters for vascular function

  16. Measurement of height and weight

    Time frame: At enrolment

    Height and weight will be measured and reported as BMI (kg/m^2)

  17. Measurement of waist and hip circumference

    Time frame: At enrolment

    Waist and hip circumference will be measured and reported as waist-to-hip ratio

  18. Blood pressure

    Time frame: At enrolment

    Blood pressure will be measured

  19. Heart rate

    Time frame: At enrolment

    Heart rate will be measured

  20. Measurement of advanced glycation endproducts

    Time frame: At enrolment

    Will be assessed by AGE reader

  21. Body composition

    Time frame: At enrolment

    Body fat content and lean mass will be assessed by bioimpedance analysis

  22. Pulmonary function (optional)

    Time frame: At enrolment

    Pulmonary function will optionally be assessed by Spiroergometric Performance Diagnostic

  23. Retinal examination

    Time frame: At enrolment

    Examination of diabetic rethinopathy by fundus photography or optionally by Optical Coherence Tomography Angiography

  24. Anamnestic and Lifestyle questionnaire

    Time frame: At enrolment

    Questions about physical activity, medical history and family background will be asked

  25. cognitive testing

    Time frame: At enrolment

    Cambridge Neuropsychological Test Automated Battery will be performed on tablet

  26. Stool examination (single stool sample)

    Time frame: At enrolment

    composition pof the gut microbiome will be assessed by 16S genome sequencing, bacterial metagenomic analysis, transcriptomics and metabolomics

  27. Macronutrient absorption (optional)

    Time frame: At enrolment

    Stool samples will be collected over multiple days and macronutrient absorption will be assessed by bomb calorimetry

  28. Nasal and skin swab

    Time frame: At enrolment

    nasal and skin swab will be collected and bacterial colonization analysed

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Fritsche, MD

CONTACT

[email protected]

+49 7071 29 80687

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2018
Primary completion
2035
Study completion
2035
First posted
Sep 5, 2018
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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