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
Scientific
Klinik für Ernährungsmedizin
Klinikum rechts der Isar der TU München
Ismaniger Strasse 22
München
81675
Germany
Phone | +49 (0)894 1406770 |
---|---|
hans.hauner@lrz.tu-muenchen.de |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | Approved by Physicians' Chamber North Rhein on 19/09/2001, reference number 2001193 |
Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
Intervention | Intense nutritional training program versus usual care |
Intervention type | Other |
Primary outcome measure | 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 study start date | 01/12/2002 |
Completion date | 01/07/2005 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 160 |
Key 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 |
Key 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 |
Date of first enrolment | 01/12/2002 |
Date of final enrolment | 01/07/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinik für Ernährungsmedizin
München
81675
Germany
81675
Germany
Sponsor information
German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG) (Germany)
Research organisation
Research organisation
Kennedyallee 40
Bonn
53175
Germany
Phone | +49 (0)228 8851 |
---|---|
postmaster@dfg.de | |
Website | http://www.dfg.de/ |
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |