Traditional Tibetan Medicine for Patients With Coronary Artery Disease - Full Text View

Sponsor:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00810992

Purpose

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).

Condition	Intervention
Coronary Artery Disease	Behavioral: Nutritional and behavioral program A Behavioral: Nutritional and behavioral program B

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Behavioral and Nutritional Therapy in Patients With Coronary Artery Disease According to Traditional Tibetan Medicine Protocol

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Diets

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Body mass index [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intima media thickness HbA1C Lipid status Platelet activation markers as prognostic biomarkers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	992
Study Start Date:	January 2009
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Program A: Active Comparator Recommendation for nutrition and behavior for patients with coronary artery disease according to the German Society of Nutritional Medicine and the International Task Force for the Prevention of Coronary Artery Disease	Behavioral: Nutritional and behavioral program A Recommendation for nutrition and behavior for patients with coronary artery disease according to the German Society of Nutritional Medicine and the International Task Force for the Prevention of Coronary Artery Disease
2 Program B: Experimental Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine	Behavioral: Nutritional and behavioral program B Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810992

Contacts

Contact: Boris Bigalke, MD	+4970712983688	boris.bigalke@med.uni-tuebingen.de
Contact: Meinrad Gawaz, MD	+4970712983688	meinrad.gawaz@med.uni-tuebingen.de

Locations

Germany
University Hospital Tübingen	Recruiting
Tübingen, Germany, 72076
Contact: Boris Bigalke, MD +4970712983688 boris.bigalke@med.uni-tuebingen.de
Principal Investigator: Boris Bigalke, MD
Sub-Investigator: Andreas E May, MD
Sub-Investigator: Stephan Lindemann, MD
Sub-Investigator: Konstantinos Stellos, MD
Sub-Investigator: Tobias Geisler, MD
Sub-Investigator: Meinrad Gawaz, MD

Sponsors and Collaborators

University Hospital Tuebingen

More Information

Additional Information:

German Society of Nutritional Medicine This link exits the ClinicalTrials.gov site

International Task Force for Prevention of Coronary Heart Disease This link exits the ClinicalTrials.gov site

Publications:

Liu L, Liu L, Ding Y, Huang Z, He B, Sun S, Zhao G, Zhang H, Miki T, Mizushima S, Ikeda K, Nara Y, Yamori Y. Ethnic and environmental differences in various markers of dietary intake and blood pressure among Chinese Han and three other minority peoples of China: results from the WHO Cardiovascular Diseases and Alimentary Comparison (CARDIAC) Study. Hypertens Res. 2001 May;24(3):315-22.

Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33.

Singh RB, Dubnov G, Niaz MA, Ghosh S, Singh R, Rastogi SS, Manor O, Pella D, Berry EM. Effect of an Indo-Mediterranean diet on progression of coronary artery disease in high risk patients (Indo-Mediterranean Diet Heart Study): a randomised single-blind trial. Lancet. 2002 Nov 9;360(9344):1455-61.

Michels KB, Wolk A. A prospective study of variety of healthy foods and mortality in women. Int J Epidemiol. 2002 Aug;31(4):847-54.

Trichopoulou A, Costacou T, Bamia C, Trichopoulos D. Adherence to a Mediterranean diet and survival in a Greek population. N Engl J Med. 2003 Jun 26;348(26):2599-608.

Bigalke B, Geisler T, Stellos K, Langer H, Daub K, Kremmer E, Seizer P, May AE, Lindemann S, Gawaz M. Platelet collagen receptor glycoprotein VI as a possible novel indicator for the acute coronary syndrome. Am Heart J. 2008 Jul;156(1):193-200. Epub 2008 Apr 23.

Bigalke B, Lindemann S, Ehlers R, Seizer P, Daub K, Langer H, Schonberger T, Kremmer E, Siegel-Axel D, May AE, Gawaz M. Expression of platelet collagen receptor glycoprotein VI is associated with acute coronary syndrome. Eur Heart J. 2006 Sep;27(18):2165-9. Epub 2006 Aug 21.

Loizzo JJ, Blackhall LJ, Rabgyay L. TIBETAN MEDICINE: A COMPLEMENTARY SCIENCE OF OPTIMAL HEALTH. Ann N Y Acad Sci. 2007 Sep 28; [Epub ahead of print]

Responsible Party:	Eberhard-Karls-Universität Tübingen ( Dr. Boris Bigalke )
Study ID Numbers:	337/2008BO1 UKT
Study First Received:	December 17, 2008
Last Updated:	January 11, 2010
ClinicalTrials.gov Identifier:	NCT00810992 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:

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)

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on March 18, 2010