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
Protocol serial number	N/A
Sponsor	German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG) (Germany)
Funder	German Research Foundation (DFG) (Germany)

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	1. Quality of life 2. Differences in compliance 3. Satisfaction with the respective therapy
Completion date	01/07/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Klinik für Ernährungsmedizin

München
81675
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan