Tübinger Diabetes Mellitus Database (TUEDID)

Diabetes Mellitus Clinical Trial

Official title:

Tübinger Diabetes Mellitus Database (TUEDID)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03658512
• Other study ID #: 247/2017BO1
• Status: Recruiting
• Start date: August 13, 2018
• Est. completion date: February 1, 2028

Study information

• Verified date: August 2022
• Source: University Hospital Tuebingen
• Contact: Andreas Fritsche, MD
• Phone: +49 7071 29 80687
• Email: andreas.fritsche[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• >18 years

Exclusion Criteria:

• no written informed consent

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
Germany	University of Tuebingen, Internal medicine IV	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Liver function	Parameters for liver function will be assessed (GOT, GPT, AP, Gamma-GT, Lipase, all [U/l])	At enrolment
Other	Renal function	Parameters for renal function will be assessed (Creatinine, Urea, Cystatin C, all [mg/dl])	At enrolment
Other	Glomerular filtration rate (GFR)	Glomerular filtration rate will be determined [ml/min/1,73 m²]	At enrolment
Other	Lipid status	Parameters for evaluation of lipid status will be assessed (LDL, HDL, Cholesterol, triglycerides, all [mg/dl])	At enrolment
Other	Inflammation	Parameters to evaluate the inflammatory state will be assessed (CRP [mg/dl])	At enrolment
Other	Insulinemia	Insulin and C-peptide concentrations will be assessed [pmol/l]	At enrolment
Other	Hormones	Parameters for evaluation of hormonal status will be assessed (TSH [mU/l])	At enrolment
Other	Hormones	Parameters for evaluation of hormonal status will be assessed (fT3 and fT4 [pmol/l])	At enrolment
Other	Hormones	Parameters for evaluation of hormonal status will be assessed (Cortisol [nmol/l])	At enrolment
Other	Urine parameters	Parameters from urine will be assessed (albumin, total protein, both [mg/l])	At enrolment
Other	Urine parameters	Parameters from urine will be assessed (creatinine [ml/min])	At enrolment
Other	Urine parameters	Parameters from urine will be assessed (urine sediment via microscopy)	At enrolment
Other	Pancreas	Lipase and amlyase concentrations for evaluation of pancreas status will be assessed [U/l]	At enrolment
Other	Coagulation	Parameters for evaluation of coagulation status will be assessed (INR, blood cell count)	At enrolment
Other	Angiological examination	Angiological examination of parameters for vascular function	At enrolment
Other	Measurement of height and weight	Height and weight will be measured and reported as BMI (kg/m^2)	At enrolment
Other	Measurement of waist and hip circumference	Waist and hip circumference will be measured and reported as waist-to-hip ratio	At enrolment
Other	Blood pressure	Blood pressure will be measured	At enrolment
Other	Heart rate	Heart rate will be measured	At enrolment
Other	Measurement of advanced glycation endproducts	Will be assessed by AGE reader	At enrolment
Other	Body composition	Body fat content and lean mass will be assessed by bioimpedance analysis	At enrolment
Other	Pulmonary function (optional)	Pulmonary function will optionally be assessed by Spiroergometric Performance Diagnostic	At enrolment
Other	Retinal examination	Examination of diabetic rethinopathy by fundus photography or optionally by Optical Coherence Tomography Angiography	At enrolment
Other	Anamnestic and Lifestyle questionnaire	Questions about physical activity, medical history and family background will be asked	At enrolment
Other	cognitive testing	Cambridge Neuropsychological Test Automated Battery will be performed on tablet	At enrolment
Other	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
Other	Macronutrient absorption (optional)	Stool samples will be collected over multiple days and macronutrient absorption will be assessed by bomb calorimetry	At enrolment
Other	Nasal and skin swab	nasal and skin swab will be collected and bacterial colonization analysed	At enrolment
Primary	Glycemic control (blood glucose)	Assessed as fasting blood glucose and HbA1C	At enrolment
Primary	Glycemic control (HbA1C)	Assessed as fasting HbA1C	At enrolment