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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 22, 2010
First Posted Date January 25, 2010
Last Update Posted Date April 19, 2023
Actual Study Start Date September 2005
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2023)
Change of insulin sensitivity (M-Value) [ Time Frame: 2 and 5 years ]
measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp
Original Primary Outcome Measures
 (submitted: January 22, 2010)
Change of insulin sensitivity (M-Value) [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures
 (submitted: April 17, 2023)
  • 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
  • Incidence of any diabetic complication [ Time Frame: 2-10 years ]
    The prevalence of diabetic complications
Original Secondary Outcome Measures
 (submitted: January 22, 2010)
  • Change of insulin secretion [ Time Frame: 5 years ]
  • Incidence of any diabetic complication [ Time Frame: 5-10 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients
Official Title Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, PBMC, serum, plasma, urine, stool
Sampling Method Non-Probability Sample
Study Population Patients are recruited from the general populations by screening
Condition
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 22, 2010)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2035
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01055093
Other Study ID Numbers GDC-Study-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party julia szendrödi, German Diabetes Center
Original Responsible Party Prof. Dr. Michael Roden, German Diabetes Center
Current Study Sponsor German Diabetes Center
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Michael Roden, Prof., MD German Diabetes Center
PRS Account German Diabetes Center
Verification Date April 2023