Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/09/2005
Date assigned
10/02/2006
Last edited
14/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dfg.de/

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

Publication citations

Additional files

Editorial Notes