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Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients (GDC)

G

German Diabetes Center

Status

Enrolling

Conditions

Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Study type

Observational

Funder types

Other

Identifiers

NCT01055093
GDC-Study-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18 to 69 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Diabetes Cohort
Description:
Prospectively followed cohort of newly diagnosed patients with diabetes mellitus, aged 18-69 years at inclusion into the study
Control Cohort
Description:
Prospectively followed cohort of glucose tolerant humans, aged 18-69 years at inclusion into the study

Trial contacts and locations

1

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Central trial contact

Robert Wagner, Prof., MD; Petra Heidkamp

Data sourced from clinicaltrials.gov

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