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Traditional Tibetan Medicine for Patients With Coronary Artery Disease (TTM in CAD)
This study has been completed.

First Received on December 17, 2008.   Last Updated on April 21, 2011   History of Changes
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
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 ]

Enrollment: 524
Study Start Date: January 2009
Study Completion Date: April 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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
 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
Experimental: 2 Program B
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

Locations
Germany
University Hospital Tübingen
Tübingen, Germany, 72076
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: Dr. Boris Bigalke, Eberhard-Karls-Universität Tübingen
ClinicalTrials.gov Identifier: NCT00810992     History of Changes
Other Study ID Numbers: 337/2008BO1 UKT
Study First Received: December 17, 2008
Last Updated: April 21, 2011
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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