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

This study is currently recruiting participants.
Verified July 2012 by German Diabetes Center
Sponsor:
Information provided by (Responsible Party):
Bettina Nowotny, German Diabetes Center
ClinicalTrials.gov Identifier:
NCT01055093
First received: January 22, 2010
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

Further study details as provided by German Diabetes Center:

Primary Outcome Measures:
  • Change of insulin sensitivity (M-Value) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of insulin secretion [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Incidence of any diabetic complication [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, PBMC, serum, plasma, urine, stool


Estimated Enrollment: 2000
Study Start Date: September 2005
Groups/Cohorts
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.
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients are recruited from the general populations by screening

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055093

Contacts
Contact: Bettina Nowotny, MD +49-211-3382-0 ext -209 studienzentrum@ddz.uni-duesseldorf.de
Contact: Petra Heidkamp +49-211-3382-0 ext -209 studienzentrum@ddz.uni-duesseldorf.de

Locations
Germany
German Diabetes Center Recruiting
Düsseldorf, North-Rhine Westphalia, Germany, 40225
Contact: Clinical Study Center     +49-211-3382-0 ext -209     studienzentrum@ddz.uni-duesseldorf.de    
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
Investigators
Principal Investigator: Michael Roden, Prof., MD German Diabetes Center
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013