search
Back to results

Traditional Tibetan Medicine for Patients With Coronary Artery Disease (TTM in CAD)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nutritional and behavioral program A
Nutritional and behavioral program B
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Tübingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1 Program A

2 Program B

Arm Description

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

Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine

Outcomes

Primary Outcome Measures

Body mass index

Secondary Outcome Measures

Intima media thickness HbA1C Lipid status Platelet activation markers as prognostic biomarkers

Full Information

First Posted
December 17, 2008
Last Updated
January 11, 2013
Sponsor
University Hospital Tuebingen
search

1. Study Identification

Unique Protocol Identification Number
NCT00810992
Brief Title
Traditional Tibetan Medicine for Patients With Coronary Artery Disease
Acronym
TTM in CAD
Official Title
Behavioral and Nutritional Therapy in Patients With Coronary Artery Disease According to Traditional Tibetan Medicine Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
524 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Program A
Arm Type
Active Comparator
Arm Description
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
Arm Title
2 Program B
Arm Type
Experimental
Arm Description
Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine
Intervention Type
Behavioral
Intervention Name(s)
Nutritional and behavioral program A
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Nutritional and behavioral program B
Intervention Description
Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine
Primary Outcome Measure Information:
Title
Body mass index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Intima media thickness HbA1C Lipid status Platelet activation markers as prognostic biomarkers
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
1973470
Citation
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. doi: 10.1016/0140-6736(90)91656-u.
Results Reference
background
PubMed Identifier
12433513
Citation
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. doi: 10.1016/S0140-6736(02)11472-3.
Results Reference
background
PubMed Identifier
12177033
Citation
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. doi: 10.1093/ije/31.4.847.
Results Reference
background
PubMed Identifier
12826634
Citation
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. doi: 10.1056/NEJMoa025039.
Results Reference
background
PubMed Identifier
18585516
Citation
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. doi: 10.1016/j.ahj.2008.02.010. Epub 2008 Apr 23.
Results Reference
background
PubMed Identifier
16923742
Citation
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. doi: 10.1093/eurheartj/ehl192. Epub 2006 Aug 21.
Results Reference
background
PubMed Identifier
11409657
Citation
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. doi: 10.1291/hypres.24.315.
Results Reference
result
PubMed Identifier
23890855
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.
Results Reference
derived
Links:
URL
http://www.dgem.de
Description
German Society of Nutritional Medicine

Learn more about this trial

Traditional Tibetan Medicine for Patients With Coronary Artery Disease

We'll reach out to this number within 24 hrs