Contact information
Type
Scientific
Primary contact
Prof Hans Hauner
ORCID ID
Contact details
Klinik für Ernährungsmedizin
Klinikum rechts der Isar der TU München
Ismaniger Strasse 22
München
81675
Germany
+49 (0)894 1406770
hans.hauner@lrz.tu-muenchen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To test the hypothesis that an intense nutritional training program (diet, knowledge about diabetes, physical activities and other lifestyle factors) can lead to reduced costs for medication, compared to the standard treatment for diabetes. Furthermore, the impact of the two therapies on the quality of life and differences in the compliance and satisfaction with the respective therapy will be investigated.
Ethics approval
Approved by Physicians' Chamber North Rhein on 19/09/2001, reference number 2001193
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Type 2 diabetes mellitus
Intervention
Intense nutritional training program versus usual care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Costs for diabetes medication in Euro
2. Cost efficiency to achieve therapy objectives
3. Fasting blood sugar 80-120 mg/dl
4. HbA1c <6.5 %
5. Blood pressure <140/85 mmHg
6. Triglyceride <150 mg/dl
7. High density lipoprotein-cholesterol >45 mg/dl
8. Low density lipoprotein-cholesterol <115 mg/dl
Secondary outcome measures
1. Quality of life
2. Differences in compliance
3. Satisfaction with the respective therapy
Overall trial start date
01/12/2002
Overall trial end date
01/07/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type 2 diabetes mellitus (the diagnosis must be made at least six months before inclusion in the study)
2. Body Mass Index (BMI) >27
3. Aged between 35 and 70 years
4. Medication with at least two anti-diabetic drugs and/or antihypertensive drugs and/or lipid-lowering drugs
5. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
1. Creatinine >2.0 mg/dl
2. Transaminase (>3 times higher than normal)
3. Alcohol or drug abuse
4. Severe psychiatric disorders
5. Eating disorders
Recruitment start date
01/12/2002
Recruitment end date
01/07/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Klinik für Ernährungsmedizin
München
81675
Germany
Sponsor information
Organisation
German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG) (Germany)
Sponsor details
Kennedyallee 40
Bonn
53175
Germany
+49 (0)228 8851
postmaster@dfg.de
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
German Research Foundation (DFG) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary