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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Bettina Nowotny, German Diabetes Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Bettina Nowotny, German Diabetes Center Identifier:
First received: January 22, 2010
Last updated: July 12, 2012
Last verified: July 2012
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.

Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients

Resource links provided by NLM:

Further study details as provided by Bettina Nowotny, German Diabetes Center:

Primary Outcome Measures:
  • Change of insulin sensitivity (M-Value) [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Change of insulin secretion [ Time Frame: 5 years ]
  • Incidence of any diabetic complication [ Time Frame: 5-10 years ]

Biospecimen Retention:   Samples With DNA
Whole blood, PBMC, serum, plasma, urine, stool

Estimated Enrollment: 2000
Study Start Date: September 2005
Observational Cohort
Prospectively followed cohort of newly diagnosed patients with diabetes mellitus aged 18-69 years at inclusion into the study

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 5 and 10 years with annual telephone contacts in between.

Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are recruited from the general populations by screening

Inclusion Criteria:

  • Clinical diagnosis of diabetes mellitus according to ADA criteria
  • Age 18-69
  • Diabetes duration since diagnosis < 12 months

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01055093

Contact: Bettina Nowotny, MD +49-211-3382-0 ext -209
Contact: Petra Heidkamp +49-211-3382-0 ext -209

German Diabetes Center Recruiting
Düsseldorf, North-Rhine Westphalia, Germany, 40225
Contact: Clinical Study Center    +49-211-3382-0 ext -209   
Principal Investigator: Michael Roden, Prof., MD         
Sub-Investigator: Bettina Nowotny, MD         
Sub-Investigator: Dan Ziegler, Prof., MD         
Sub-Investigator: Guido Giani, Prof.         
Sub-Investigator: Wolfgang Rathmann, MD, MSPH         
Sub-Investigator: Nanette C Schloot, MD         
Sub-Investigator: Christian Herder, PhD, M.Sci.         
Sub-Investigator: Peter Schadewaldt, Prof., PhD         
Sub-Investigator: Andrea Icks, MD         
Sub-Investigator: Joachim Rosenbauer, Ph.D.         
Sub-Investigator: Jörg Kotzka, Ph.D.         
Sponsors and Collaborators
German Diabetes Center
Principal Investigator: Michael Roden, Prof., MD German Diabetes Center
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Bettina Nowotny, Dr. Bettina Nowotny, M.Sc., German Diabetes Center Identifier: NCT01055093     History of Changes
Other Study ID Numbers: GDC-Study-01
Study First Received: January 22, 2010
Last Updated: July 12, 2012

Keywords provided by Bettina Nowotny, German Diabetes Center:
diabetes mellitus
prospective observational study
diabetic complications

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases processed this record on May 25, 2017