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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Andreas Fritsche, MD; Phone Number: +49 7071 29 80687; Email: andreas.fritsche@med.uni-tuebingen.de

Study Locations

• Germany
  • Tuebingen, Germany, 72074
    • Recruiting
    • University of Tuebingen, Internal medicine IV
    • Principal Investigator: Andreas Fritsche, MD
    • Contact: Andreas Fritsch, Prof, MD; Phone Number: 82711 +49 7071 29; Email: andreas.fritsche@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with or without diabetes who are treated at the University Hospital Tübingen

Description

Inclusion Criteria:

• >18 years

Exclusion Criteria:

• no written informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TUEDID cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control (blood glucose)	Assessed as fasting blood glucose and HbA1C	At enrolment
Glycemic control (HbA1C)	Assessed as fasting HbA1C	At enrolment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver function	Parameters for liver function will be assessed (GOT, GPT, AP, Gamma-GT, Lipase, all [U/l])	At enrolment
Renal function	Parameters for renal function will be assessed (Creatinine, Urea, Cystatin C, all [mg/dl])	At enrolment
Glomerular filtration rate (GFR)	Glomerular filtration rate will be determined [ml/min/1,73 m²]	At enrolment
Lipid status	Parameters for evaluation of lipid status will be assessed (LDL, HDL, Cholesterol, triglycerides, all [mg/dl])	At enrolment
Inflammation	Parameters to evaluate the inflammatory state will be assessed (CRP [mg/dl])	At enrolment
Insulinemia	Insulin and C-peptide concentrations will be assessed [pmol/l]	At enrolment
Hormones	Parameters for evaluation of hormonal status will be assessed (TSH [mU/l])	At enrolment
Hormones	Parameters for evaluation of hormonal status will be assessed (fT3 and fT4 [pmol/l])	At enrolment
Hormones	Parameters for evaluation of hormonal status will be assessed (Cortisol [nmol/l])	At enrolment
Urine parameters	Parameters from urine will be assessed (albumin, total protein, both [mg/l])	At enrolment
Urine parameters	Parameters from urine will be assessed (creatinine [ml/min])	At enrolment
Urine parameters	Parameters from urine will be assessed (urine sediment via microscopy)	At enrolment
Pancreas	Lipase and amlyase concentrations for evaluation of pancreas status will be assessed [U/l]	At enrolment
Coagulation	Parameters for evaluation of coagulation status will be assessed (INR, blood cell count)	At enrolment
Angiological examination	Angiological examination of parameters for vascular function	At enrolment
Measurement of height and weight	Height and weight will be measured and reported as BMI (kg/m^2)	At enrolment
Measurement of waist and hip circumference	Waist and hip circumference will be measured and reported as waist-to-hip ratio	At enrolment
Blood pressure	Blood pressure will be measured	At enrolment
Heart rate	Heart rate will be measured	At enrolment
Measurement of advanced glycation endproducts	Will be assessed by AGE reader	At enrolment
Body composition	Body fat content and lean mass will be assessed by bioimpedance analysis	At enrolment
Pulmonary function (optional)	Pulmonary function will optionally be assessed by Spiroergometric Performance Diagnostic	At enrolment
Retinal examination	Examination of diabetic rethinopathy by fundus photography or optionally by Optical Coherence Tomography Angiography	At enrolment
Anamnestic and Lifestyle questionnaire	Questions about physical activity, medical history and family background will be asked	At enrolment
cognitive testing	Cambridge Neuropsychological Test Automated Battery will be performed on tablet	At enrolment
Stool examination (single stool sample)	composition pof the gut microbiome will be assessed by 16S genome sequencing, bacterial metagenomic analysis, transcriptomics and metabolomics	At enrolment
Macronutrient absorption (optional)	Stool samples will be collected over multiple days and macronutrient absorption will be assessed by bomb calorimetry	At enrolment
Nasal and skin swab	nasal and skin swab will be collected and bacterial colonization analysed	At enrolment

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Anticipated): February 1, 2028
• Study Completion (Anticipated): February 1, 2028

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 247/2017BO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No