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| 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: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung |
| Estimated Enrollment: | 248 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Telephone counseling
|
Other: Telephone counseling
telephone counseling is executed once a months by the medical secretary of the general practitioners practices
|
|
2: No Intervention
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| Germany, Baden-Württemberg | |
| Jürgen Wirth, MD | Recruiting |
| Marbach Am Neckar, Baden-Württemberg, Germany, 71672 | |
| Contact: Jürgen Wirth, MD 0049-7144-858347 | |
| Michael Spiel, MD | Recruiting |
| Murr, Baden-Württemberg, Germany, 71711 | |
| Contact: Michael Spiel, MD 0049-7144-22060 | |
| Ulf-Michael Werner, MD | Recruiting |
| Remshalden, Baden-Württemberg, Germany, 73630 | |
| Contact: Ulf-Michael Werner, MD 0046-7181-484977 | |
| Ulrich Hofmann, MD | Recruiting |
| Ilsfeld-Auenstein, Baden-Württemberg, Germany, 74360 | |
| Contact: Ulrich Hofmann, MD 0049-7062-95030 | |
| Andrea Walliser-Klöpfer, MD | Recruiting |
| Benningen Am Neckar, Baden-Württemberg, Germany, 71724 | |
| Contact: Andrea Walliser-Klöpfer, MD 0049-7144-14233 | |
| Franz Lang, MD | Recruiting |
| Marbach Am Neckar, Baden-Württemberg, Germany, 71672 | |
| Contact: Franz Lang, MD 0049-7144-5137 | |
| Jürgen Herbers, MD | Recruiting |
| Pleidelsheim, Baden-Württemberg, Germany, 74385 | |
| Contact: Jürgen Herbers, MD 0049-7144-82730 | |
| Ullrich Barthelmes, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74080 | |
| Contact: Ullrich Barthelmes, MD 0049-7131-41414 | |
| Ulrich Wagner, MD | Recruiting |
| Ludwigsburg, Baden-Württemberg, Germany, 71634 | |
| Contact: Ulrich Wagner, MD 0049-7141-926584 | |
| Martin Heinrich, MD | Recruiting |
| Ludwigsburg, Baden-Württemberg, Germany, 71640 | |
| Contact: Martin Heinrich, MD 0049-7141-86777 | |
| Dieter Böhm, MD | Withdrawn |
| Steinheim An Der Murr, Baden-Württemberg, Germany, 71711 | |
| Jürgen Wollweber, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74072 | |
| Contact: Jürgen Wollweber, MD 0049-7131-84477 | |
| Kurt Weber, MD | Recruiting |
| Weissach, Baden-Württemberg, Germany, 71287 | |
| Contact: Kurt Weber, MD 0049-7044-971720 | |
| Odilo Schnabel, MD | Recruiting |
| Zaberfeld, Baden-Württemberg, Germany, 74374 | |
| Contact: Odilo Schnabel, MD 0049-7046-321 | |
| Adelheid Halttunen, MD | Recruiting |
| Gemmingen, Baden-Württemberg, Germany, 75050 | |
| Contact: Adelheid Halttungen, MD 0049-7267-911100 | |
| Andreas Wößner, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74078 | |
| Contact: Andreas Wößner, MD 0049-7131-44079 | |
| Hartmut Jungjohann, MD | Recruiting |
| Neckarsulm, Baden-Württemberg, Germany, 74172 | |
| Contact: Hartmut Jungjohann, MD 0049-7131-88100 | |
| Eberhard Rieker, MD | Recruiting |
| Lauffen Am Neckar, Baden-Württemberg, Germany, 74348 | |
| Contact: Eberhard Rieker, MD 0049-7133-7992 | |
| Dietmar Kunz, MD | Recruiting |
| Neckarsulm, Baden-Württemberg, Germany, 74172 | |
| Contact: Dietmar Kunz, MD 0049-7132-88416 | |
| Sigmund Jakob | Recruiting |
| Weinsberg, Baden-Württemberg, Germany, 74189 | |
| Contact: Sigmund Jakob, MD 0049-7134-8583 | |
| Gerhard Günther, MD | Recruiting |
| Leonberg, Baden-Württemberg, Germany, 71229 | |
| Contact: Gerhard Günther, MD 0049-7152-23498 | |
| Hans Martin Schweizer, MD | Recruiting |
| Korntal, Baden-Württemberg, Germany, 70825 | |
| Contact: Hans M Schweizer, MD 0049-711-831768 | |
| Thomas Baartz, MD | Recruiting |
| Leonberg, Baden-Württemberg, Germany, 71229 | |
| Contact: Thomas Baartz, MD 0049-7152-21486 | |
| Hans-Joachim Essich, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74072 | |
| Contact: Hans-Joachim Essich, MD 0049-7131-81802 | |
| Christoph Lücke, MD | Recruiting |
| Beilstein, Baden-Württemberg, Germany, 71717 | |
| Contact: Christoph Lücke, MD 0049-7062-4444 | |
| Miroslaw Wyszynski, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74081 | |
| Contact: Miroslaw Wyszynski, MD 0049-7131-85187 | |
| Gisela Gramlich, MD | Recruiting |
| Untergruppenbach, Baden-Württemberg, Germany, 74199 | |
| Contact: Gisela Gramlich, MD 0049-7131-70775 | |
| Karl Schütz, MD | Recruiting |
| Weinsberg, Baden-Württemberg, Germany, 74189 | |
| Contact: Karl Schütz, MD 0049-7134-8843 | |
| Hans-Jürgen Sommerer, MD | Recruiting |
| Neckarsulm, Baden-Württemberg, Germany, 74081 | |
| Contact: Hans-Jürgen Sommerer, MD 0049-7132-18688 | |
| Axel Möller, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74081 | |
| Contact: Axel Möller, MD 0049-7131-5823411 | |
| Dietmar Zinßer, MD | Recruiting |
| Winnenden, Baden-Württemberg, Germany, 71364 | |
| Contact: Dietmar Zinßer, MD 0049-7195-174733 | |
| Alfred Preisner, MD | Recruiting |
| Massenbachhausen, Baden-Württemberg, Germany, 74252 | |
| Contact: Alfred Preisner, MD 0049-7138-7065 | |
| Monika Muhler, MD | Recruiting |
| Loewenstein, Baden-Württemberg, Germany, 74245 | |
| Contact: Monika Muhler, MD 0049-7130-402659 | |
| Nader Heydari, MD | Recruiting |
| Fellbach, Baden-Württemberg, Germany, 70737 | |
| Contact: Nader Heydari, MD 0049-711-589003 | |
| Bernd Leuchs, MD | Recruiting |
| Leonberg, Baden-Württemberg, Germany, 71229 | |
| Contact: Bernd Leuchs, MD 0049-7152-43245 | |
| Frank Röder, MD | Recruiting |
| Schwaikheim, Baden-Württemberg, Germany, 71409 | |
| Contact: Frank Röder, MD 0049-7195-53866 | |
| Ildiko Tasic | Recruiting |
| Vaihingen-Enz, Baden-Württemberg, Germany, 71665 | |
| Contact: Ildiko Tasic, MD 0049-7042-5310 | |
| Volker Naser, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74076 | |
| Contact: Volker Naser, MD 0049-7131-161295 | |
| Principal Investigator: | Hermann Brenner, MD, MPH | German Cancer Research Center |
More Information
| Responsible Party: | German Cancer Research Center ( Prof. Dr. med. Hermann Brenner ) |
| Study ID Numbers: | S-r86/zoo8 |
| Study First Received: | August 26, 2008 |
| Last Updated: | December 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00742547 History of Changes |
| Health Authority: | Germany: Ethics Commission; Germany: Federal Ministry of Education and Research |
|
prevention health services research |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |
