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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00742547
Date of registration: 26/08/2008
Prospective Registration: Yes
Primary sponsor: German Cancer Research Center
Public title: Type 2 Diabetes Mellitus: New Approaches to Optimize Medical Care in General Practice DIANA
Scientific title: DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung
Date of first enrolment: October 2008
Target sample size: 204
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00742547
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention  
Phase:  N/A
Countries of recruitment
Germany
Contacts
Name:     Hermann Brenner, MD, MPH
Address: 
Telephone:
Email:
Affiliation:  German Cancer Research Center
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Type 2 Diabetes Mellitus
Intervention(s)
Other: Telephone counseling
Primary Outcome(s)
HbA1c [Time Frame: 18 months]
Secondary Outcome(s)
risk factor control (eg. body weight, physical activity, smoking) [Time Frame: 18 months]
lipid metabolism control [Time Frame: 18 months]
incidence of diabetes-related complications [Time Frame: 18 months]
health-related quality of life [Time Frame: 18 months]
CHD, mortality [Time Frame: 18 months]
hospitalization [Time Frame: 18 month]
Secondary ID(s)
S-r86/zoo8
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
German Federal Ministry of Education and Research
Heidelberg University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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