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Type 2 Diabetes Mellitus: New Approaches to Optimize Medical Care in General Practice (DIANA)
This study is currently recruiting participants.
Verified June 2011 by German Cancer Research Center

First Received on August 26, 2008.   Last Updated on June 14, 2011   History of Changes
Sponsor: German Cancer Research Center
Collaborators: University of Heidelberg
German Federal Ministry of Education and Research
Information provided by: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT00742547
  Purpose

Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In an epidemiological longitudinal study of about 1.500 patients with type-2 diabetes mellitus we investigate determinants and predictors for long-term prognosis. The patients are recruited and supervised in practices of general practitioners of the administrative district of Ludwigsburg (Baden-Württemberg, Germany). In a subgroup of about 248 patients with a dissatisfactory metabolic status ( > 7,5%) a randomised interventional study is performed. The intervention comprises a telephone counseling by the medical secretary of each practice executed in a predefined period of time. The outcome parameters of interest are the change of HbA1c, the development of secondary disorders and adverse events, as well as hospitalization and mortality.

The aim of the study is to develop an patient-orientated instrument implementable in the "normal" medical care in order to enhance the prognosis of patients with type-2 diabetes mellitus.


Condition Intervention
Type 2 Diabetes Mellitus
 Other: Telephone counseling
Other: No telephone counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus
MedlinePlus related topics: Diabetes Diabetes Type 2
U.S. FDA Resources

Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hospitalization [ Time Frame: 18 month ] [ Designated as safety issue: No ]
  • CHD [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 248
Study Start Date: October 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Telephone counseling
 Other: Telephone counseling
telephone counseling is executed once a months by the medical secretary of the general practitioners practices
No Intervention: 2
No telephone counseling
 Other: No telephone counseling
The control group does not get a telephone counseling.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with type-2 diabetes mellitus attending the general practitioner's in the time from October to December 2008
  • Ability to take part in the study

Exclusion Criteria:

  • Nursing home resident
  • Insufficient knowledge of the German language
  • Palliative health care with limited life expectancy
  • Emergency outpatient
  • All outpatients who attend the general practitioner by way of exception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742547

Contacts
Contact: Hermann Brenner, MD, MPH 0049-6221-548140 h.brenner@dkfz-heidelberg.de
Contact: Elke Raum, MD, MPH 0049-6221-548143 e.raum@dkfz-heidelberg.de

Locations
Germany
Christoph Lücke, MD Recruiting
Beilstein, Baden-Württemberg, Germany, 71717
Contact: Christoph Lücke, MD     0049-7062-4444        
Andrea Walliser-Klöpfer, MD Recruiting
Benningen am Neckar, Baden-Württemberg, Germany, 71724
Contact: Andrea Walliser-Klöpfer, MD     0049-7144-14233        
Nader Heydari, MD Recruiting
Fellbach, Baden-Württemberg, Germany, 70737
Contact: Nader Heydari, MD     0049-711-589003        
Adelheid Halttunen, MD Recruiting
Gemmingen, Baden-Württemberg, Germany, 75050
Contact: Adelheid Halttungen, MD     0049-7267-911100        
Jürgen Wollweber, MD Recruiting
Heilbronn, Baden-Württemberg, Germany, 74072
Contact: Jürgen Wollweber, MD     0049-7131-84477        
Axel Möller, MD Recruiting
Heilbronn, Baden-Württemberg, Germany, 74081
Contact: Axel Möller, MD     0049-7131-5823411        
Miroslaw Wyszynski, MD Recruiting
Heilbronn, Baden-Württemberg, Germany, 74081
Contact: Miroslaw Wyszynski, MD     0049-7131-85187        
Ullrich Barthelmes, MD Recruiting
Heilbronn, Baden-Württemberg, Germany, 74080
Contact: Ullrich Barthelmes, MD     0049-7131-41414        
Volker Naser, MD Recruiting
Heilbronn, Baden-Württemberg, Germany, 74076
Contact: Volker Naser, MD     0049-7131-161295        
Hans-Joachim Essich, MD Recruiting
Heilbronn, Baden-Württemberg, Germany, 74072
Contact: Hans-Joachim Essich, MD     0049-7131-81802        
Andreas Wößner, MD Recruiting
Heilbronn, Baden-Württemberg, Germany, 74078
Contact: Andreas Wößner, MD     0049-7131-44079        
Ulrich Hofmann, MD Recruiting
Ilsfeld-Auenstein, Baden-Württemberg, Germany, 74360
Contact: Ulrich Hofmann, MD     0049-7062-95030        
Hans Martin Schweizer, MD Recruiting
Korntal, Baden-Württemberg, Germany, 70825
Contact: Hans M Schweizer, MD     0049-711-831768        
Eberhard Rieker, MD Recruiting
Lauffen am Neckar, Baden-Württemberg, Germany, 74348
Contact: Eberhard Rieker, MD     0049-7133-7992        
Bernd Leuchs, MD Recruiting
Leonberg, Baden-Württemberg, Germany, 71229
Contact: Bernd Leuchs, MD     0049-7152-43245        
Gerhard Günther, MD Recruiting
Leonberg, Baden-Württemberg, Germany, 71229
Contact: Gerhard Günther, MD     0049-7152-23498        
Thomas Baartz, MD Recruiting
Leonberg, Baden-Württemberg, Germany, 71229
Contact: Thomas Baartz, MD     0049-7152-21486        
Monika Muhler, MD Recruiting
Loewenstein, Baden-Württemberg, Germany, 74245
Contact: Monika Muhler, MD     0049-7130-402659        
Martin Heinrich, MD Recruiting
Ludwigsburg, Baden-Württemberg, Germany, 71640
Contact: Martin Heinrich, MD     0049-7141-86777        
Ulrich Wagner, MD Recruiting
Ludwigsburg, Baden-Württemberg, Germany, 71634
Contact: Ulrich Wagner, MD     0049-7141-926584        
Jürgen Wirth, MD Recruiting
Marbach am Neckar, Baden-Württemberg, Germany, 71672
Contact: Jürgen Wirth, MD     0049-7144-858347        
Franz Lang, MD Recruiting
Marbach am Neckar, Baden-Württemberg, Germany, 71672
Contact: Franz Lang, MD     0049-7144-5137        
Alfred Preisner, MD Recruiting
Massenbachhausen, Baden-Württemberg, Germany, 74252
Contact: Alfred Preisner, MD     0049-7138-7065        
Michael Spiel, MD Recruiting
Murr, Baden-Württemberg, Germany, 71711
Contact: Michael Spiel, MD     0049-7144-22060        
Hartmut Jungjohann, MD Recruiting
Neckarsulm, Baden-Württemberg, Germany, 74172
Contact: Hartmut Jungjohann, MD     0049-7131-88100        
Hans-Jürgen Sommerer, MD Recruiting
Neckarsulm, Baden-Württemberg, Germany, 74081
Contact: Hans-Jürgen Sommerer, MD     0049-7132-18688        
Dietmar Kunz, MD Recruiting
Neckarsulm, Baden-Württemberg, Germany, 74172
Contact: Dietmar Kunz, MD     0049-7132-88416        
Jürgen Herbers, MD Recruiting
Pleidelsheim, Baden-Württemberg, Germany, 74385
Contact: Jürgen Herbers, MD     0049-7144-82730        
Ulf-Michael Werner, MD Recruiting
Remshalden, Baden-Württemberg, Germany, 73630
Contact: Ulf-Michael Werner, MD     0046-7181-484977        
Frank Röder, MD Recruiting
Schwaikheim, Baden-Württemberg, Germany, 71409
Contact: Frank Röder, MD     0049-7195-53866        
Dieter Böhm, MD Withdrawn
Steinheim an der Murr, Baden-Württemberg, Germany, 71711
Gisela Gramlich, MD Recruiting
Untergruppenbach, Baden-Württemberg, Germany, 74199
Contact: Gisela Gramlich, MD     0049-7131-70775        
Ildiko Tasic Recruiting
Vaihingen-Enz, Baden-Württemberg, Germany, 71665
Contact: Ildiko Tasic, MD     0049-7042-5310        
Sigmund Jakob Recruiting
Weinsberg, Baden-Württemberg, Germany, 74189
Contact: Sigmund Jakob, MD     0049-7134-8583        
Karl Schütz, MD Recruiting
Weinsberg, Baden-Württemberg, Germany, 74189
Contact: Karl Schütz, MD     0049-7134-8843        
Kurt Weber, MD Recruiting
Weissach, Baden-Württemberg, Germany, 71287
Contact: Kurt Weber, MD     0049-7044-971720        
Dietmar Zinßer, MD Recruiting
Winnenden, Baden-Württemberg, Germany, 71364
Contact: Dietmar Zinßer, MD     0049-7195-174733        
Odilo Schnabel, MD Recruiting
Zaberfeld, Baden-Württemberg, Germany, 74374
Contact: Odilo Schnabel, MD     0049-7046-321        
Sponsors and Collaborators
German Cancer Research Center
University of Heidelberg
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Hermann Brenner, MD, MPH German Cancer Research Center
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Hermann Brenner, German Cancer Research Center
ClinicalTrials.gov Identifier: NCT00742547     History of Changes
Other Study ID Numbers: S-r86/zoo8
Study First Received: August 26, 2008
Last Updated: June 14, 2011
Health Authority: Germany: Ethics Commission;   Germany: Federal Ministry of Education and Research

Keywords provided by German Cancer Research Center:
prevention
health services research

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

ClinicalTrials.gov processed this record on February 09, 2012



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