An intense nutritional training program for obese patients with type 2 diabetes mellitus: a randomised controlled two-year intervention study

ISRCTN ISRCTN30261920
DOI https://doi.org/10.1186/ISRCTN30261920
Secondary identifying numbers N/A
Submission date
07/09/2005
Registration date
10/02/2006
Last edited
14/10/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hans Hauner
Scientific

Klinik für Ernährungsmedizin
Klinikum rechts der Isar der TU München
Ismaniger Strasse 22
München
81675
Germany

Phone +49 (0)894 1406770
Email hans.hauner@lrz.tu-muenchen.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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(s)Approved by Physicians' Chamber North Rhein on 19/09/2001, reference number 2001193
Health condition(s) or problem(s) studiedType 2 diabetes mellitus
InterventionIntense nutritional training program versus usual care
Intervention typeOther
Primary outcome measure1. 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 measures1. Quality of life
2. Differences in compliance
3. Satisfaction with the respective therapy
Overall study start date01/12/2002
Completion date01/07/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants160
Key inclusion criteria1. 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
Key exclusion criteria1. Creatinine >2.0 mg/dl
2. Transaminase (>3 times higher than normal)
3. Alcohol or drug abuse
4. Severe psychiatric disorders
5. Eating disorders
Date of first enrolment01/12/2002
Date of final enrolment01/07/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

Klinik für Ernährungsmedizin
München
81675
Germany

Sponsor information

German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG) (Germany)
Research organisation

Kennedyallee 40
Bonn
53175
Germany

Phone +49 (0)228 8851
Email postmaster@dfg.de
Website http://www.dfg.de/
ROR logo "ROR" https://ror.org/018mejw64

Funders

Funder type

Research organisation

German Research Foundation (DFG) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan