Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-69
SponsorGerman Diabetes Center
About this trial
The aim of the prospective observational GDC-Study in patients with newly diagnosed diabetes mellitus aged 18-69 years at inclusion into the study is to characterize in detail the clinical, metabolical and immunological phenotype and monitor the progression of the disease and to compare the phenotype to glucose tolerant humans of similar age, body mass and sex distribution.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Diabetes mellitus category 3 B-H (ADA criteria)
Pregnancy
Severe renal, liver or heart disease
malignant cancer
Trial population
Patients are recruited from the general populations by screening
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 2 trial groupsGroup A: Diabetes Cohort
Group B: Control Cohort
Trial outcomes
Primary outcomes
1
Change of insulin sensitivity (M-Value)
measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp
Time frame
2 and 5 yearsSecondary outcomes
1
Change of insulin secretion
measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test
Time frame
2 and 5 years2
Incidence of any diabetic complication
The prevalence of diabetic complications
Time frame
2-10 yearsSponsors and contacts
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Source ClinicalTrials.gov