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

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ClinicalTrials.gov Identifier: NCT01055093
Recruitment Status : Recruiting
First Posted : January 25, 2010
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
julia szendrödi, German Diabetes Center

Study Description
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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.

Condition or disease
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients
Actual Study Start Date : September 2005
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2035

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Change of insulin sensitivity (M-Value) [ Time Frame: 2 and 5 years ]
    measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp


Secondary Outcome Measures :
  1. Change of insulin secretion [ Time Frame: 2 and 5 years ]
    measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test

  2. Incidence of any diabetic complication [ Time Frame: 2-10 years ]
    The prevalence of diabetic complications


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055093


Contacts
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Contact: Julia Szendrödi, MD +49-211-3382-0 ext -209 studienzentrum@ddz.de
Contact: Petra Heidkamp +49-211-3382-0 ext -209 studienzentrum@ddz.de

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

Publications of Results:

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

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Responsible Party: julia szendrödi, Dr. Julia Szendrödi, German Diabetes Center
ClinicalTrials.gov Identifier: NCT01055093    
Other Study ID Numbers: GDC-Study-01
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023
Keywords provided by julia szendrödi, German Diabetes Center:
diabetes mellitus
prospective observational study
diabetic complications
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases