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NCT Number: NCT01055093

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location status: Recruiting

Location contact

Andrea Icks, MD

SUB_INVESTIGATOR

Christian Herder, PhD, M.Sci.

SUB_INVESTIGATOR

Clinical Study Center

CONTACT

[email protected]

+49-211-3382-0 ext. -209

Dan Ziegler, Prof., MD

SUB_INVESTIGATOR

Joachim Rosenbauer, Ph.D.

SUB_INVESTIGATOR

Jörg Kotzka, Ph.D.

SUB_INVESTIGATOR

Michael Roden, Prof., MD

PRINCIPAL_INVESTIGATOR

Wolfgang Rathmann, MD, MSPH

SUB_INVESTIGATOR

About this study

In detail, the following questions will be answered:

  • Are there different phenotypes with respect to insulin secretion, insulin sensitivity, micro- and macrovascular status and diabetic neuropathy at time of diagnosis?
  • Which factors modify the progression of the disease (Nutrition, subclinical inflammation, energy metabolism and physical activity)?
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change of insulin sensitivity (M-Value)

    Time frame: 2 and 5 years

    measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Petra Heidkamp

CONTACT

[email protected]

+49-211-3382 ext. -209

Robert Wagner, Prof., MD

CONTACT

[email protected]

+49-211-3382 ext. -277

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Registry information

Acronym: GDC

Important dates

Study start
2005
Primary completion
2030
Study completion
2040
First posted
Jan 25, 2010
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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