Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- German Diabetes Center
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Change of insulin sensitivity (M-Value)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Detailed Description
In detail, the following questions will be answered: 1. Are there different phenotypes with respect to insulin secretion, insulin sensitivity, micro- and macrovascular status and diabetic neuropathy at time of diagnosis? 2. Which factors modify the progression of the disease (Nutrition, subclinical inflammation, energy metabolism and physical activity)? 3. Can we identify subgroups at baseline with different progression of the disease? Patients are thoroughly examined at baseline and after 2, 5, and 10 years with annual telephone contacts in between.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Diabetes mellitus category 3 B-H (ADA criteria)
- •Pregnancy
- •Severe renal, liver or heart disease
- •malignant cancer
- •severe psychiatric illness or addiction
- •participation in an intervention trial
Outcomes
Primary Outcomes
Change of insulin sensitivity (M-Value)
Time Frame: 2 and 5 years
measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp
Secondary Outcomes
- Incidence of any diabetic complication(2-10 years)
- Change of insulin secretion(2 and 5 years)