Clinical trial NCT00810992: Traditional Tibetan Medicine for Patients With Coronary Artery Disease
Official title: Behavioral and Nutritional Therapy in Patients With Coronary Artery Disease According to Traditional Tibetan Medicine Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: dietary, behavior
IDF criteria
coronary artery disease
Traditional Tibetan Medicine
coronary artery disease in patients, who have an increased cardiovascular risk profile according to the criteria by the International Diabetes Federation (IDF)
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coronary artery disease has a high death toll in the Western world. Changes in lifestyle, particularly in nutrition and physical activity may significantly reduce a severe coronary atherosclerosis within one year without the use of medication. Several dietary studies have shown that not only the progress of coronary artery disease can be slowed down, but it may also increase significantly the survival of these patients.

Up until now there is little known about therapeutic effects by complementary medicine. In particular, Traditional Tibetan medicine dietary programs have shown in few case reports that weight could be reduced in patients with obesity.

Therefore, the investigators developed a specific dietary program for patients with coronary artery disease, who have an increased cardiovascular risk profile according to the criteria by the International Diabetes Federation (IDF).


Eligibility criteria: Inclusion Criteria:

* \>= 18 years old
* male and female
* coronary artery disease
* criteria of International Diabetes Federation (IDF)

Exclusion Criteria:

* \<18 years old
* incapability for informed consent
* history of malignity, psychiatric disorder, tissue, thyroid gland and renal diseases, anorexia or bulimia
* administration of steroids or hormones
* pregnancy
* body mass index \< 25

Primary outcomes:
measure: Body mass index
timeFrame: 6 months
Secondary outcomes:
measure: Intima media thickness HbA1C Lipid status Platelet activation markers as prognostic biomarkers
timeFrame: 6 months
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
References:
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citation: von Haehling S, Stellos K, Qusar N, Gawaz M, Bigalke B. Weight reduction in patients with coronary artery disease: comparison of Traditional Tibetan Medicine and Western diet. Int J Cardiol. 2013 Sep 30;168(2):1509-15. doi: 10.1016/j.ijcard.2013.07.034. Epub 2013 Jul 26.