This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by julia szendrödi, German Diabetes Center
Sponsor:
Information provided by (Responsible Party):
julia szendrödi, German Diabetes Center
ClinicalTrials.gov Identifier:
NCT01055093
First received: January 22, 2010
Last updated: September 11, 2017
Last verified: September 2017
  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 and to compare the phenotype to glucose tolerant humans of similar age, body mass and sex distribution.

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:


Further study details as provided by julia szendrödi, German Diabetes Center:

Primary Outcome Measures:
  • Change of insulin sensitivity (M-Value) [ Time Frame: 2 and 5 years ]

Secondary Outcome Measures:
  • Change of insulin secretion [ Time Frame: 2 and 5 years ]
  • Incidence of any diabetic complication [ Time Frame: 2-10 years ]

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

Estimated Enrollment: 2000
Actual Study Start Date: September 2005
Estimated Study Completion Date: September 2035
Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes Cohort
Prospectively followed cohort of newly diagnosed patients with diabetes mellitus, aged 18-69 years at inclusion into the study
Control Cohort
Prospectively followed cohort of glucose tolerant humans, 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 2, 5, and 10 years with annual telephone contacts in between.
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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
  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 ClinicalTrials.gov identifier: NCT01055093

Contacts
Contact: Julia Szendrödi, 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: Dan Ziegler, Prof., MD         
Sub-Investigator: Christian Herder, PhD, M.Sci.         
Sub-Investigator: Wolfgang Rathmann, MD, MSPH         
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

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

Responsible Party: julia szendrödi, Dr. Julia Szendrödi, 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: September 11, 2017

Keywords provided by julia szendrödi, 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

ClinicalTrials.gov processed this record on September 21, 2017