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Tübinger Diabetes Mellitus Database (TUEDID)

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Recruiting
CT.gov ID
NCT03658512
Collaborator
(none)
1,000
Enrollment
1
Location
113.6
Anticipated Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Tübinger Diabetes Mellitus Database (TUEDID)
    Actual Study Start Date :
    Aug 13, 2018
    Anticipated Primary Completion Date :
    Feb 1, 2028
    Anticipated Study Completion Date :
    Feb 1, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    TUEDID cohort

    Outcome Measures

    Primary Outcome Measures

    1. Glycemic control (blood glucose) [At enrolment]

      Assessed as fasting blood glucose and HbA1C

    2. Glycemic control (HbA1C) [At enrolment]

      Assessed as fasting HbA1C

    Other Outcome Measures

    1. Liver function [At enrolment]

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

    2. Renal function [At enrolment]

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

    3. Glomerular filtration rate (GFR) [At enrolment]

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

    4. Lipid status [At enrolment]

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

    5. Inflammation [At enrolment]

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

    6. Insulinemia [At enrolment]

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

    7. Hormones [At enrolment]

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

    8. Hormones [At enrolment]

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

    9. Hormones [At enrolment]

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

    10. Urine parameters [At enrolment]

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

    11. Urine parameters [At enrolment]

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

    12. Urine parameters [At enrolment]

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

    13. Pancreas [At enrolment]

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

    14. Coagulation [At enrolment]

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

    15. Angiological examination [At enrolment]

      Angiological examination of parameters for vascular function

    16. Measurement of height and weight [At enrolment]

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

    17. Measurement of waist and hip circumference [At enrolment]

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

    18. Blood pressure [At enrolment]

      Blood pressure will be measured

    19. Heart rate [At enrolment]

      Heart rate will be measured

    20. Measurement of advanced glycation endproducts [At enrolment]

      Will be assessed by AGE reader

    21. Body composition [At enrolment]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 18 years

    Exclusion Criteria:
    • no written informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Tuebingen, Internal medicine IV Tuebingen Germany 72074

    Sponsors and Collaborators

    • University Hospital Tuebingen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT03658512
    Other Study ID Numbers:
    • 247/2017BO1
    First Posted:
    Sep 5, 2018
    Last Update Posted:
    Jun 25, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus

    Study Results

    No Results Posted as of Jun 25, 2021