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Innovative Strategies For Risk Reduction Following CABG
This study is currently recruiting participants.
Verified by St. Michael's Hospital, Toronto, July 2008
Sponsors and Collaborators: St. Michael's Hospital, Toronto
Canadian Diabetes Association
Information provided by: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00462436
  Purpose

Background: Treatment targets for cardiac risk factor reduction are not being met. Therefore, there is a need for new strategies to assist patients in meeting these goals.

Objective: To determine the amount of any additional benefit on risk factor reduction associated with the consumption of the "dietary portfolio" (a low fat diet with soy, nuts and viscous fibres), above that achieved with medical management in diabetic patients following cardiac surgery.

Description: 35 cardiac surgery patients with diabetes will be instructed on how to incorporate the dietary portfolio foods into their diet for four weeks. Changes in blood cholesterol, markers of inflammation, blood sugar control and modifiable risk factors will be assessed after 2 and 4 weeks of therapy.

Relevance: Maximizing cardiac risk factor reduction through a combined approach (dietary plus medication) should improve outcomes, reduce rates of re-hospitalization and improve quality of life in diabetic patients after heart surgery.


Condition Intervention Phase
Coronary Artery Disease
Type II Diabetes Mellitus
 Behavioral: Consumption of Dietary Portfolio
 Phase II

MedlinePlus related topics: Cholesterol Coronary Artery Disease Diabetes
Drug Information available for: Cholest-5-en-3-ol (3beta)- Proteins, soy
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Do Innovative Strategies Complement Medical Management to Reduce Cardiovascular Risk Factors Following Coronary Artery Bypass Graft Surgery?

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Primary Outcome: Reduction of total and LDL cholesterol [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in endothelial function and EPC counts [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
  • Reduction in CRP [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]
  • Feasibility and tolerability [ Time Frame: Baseline to 4 Weeks ] [ Designated as safety issue: No ]
  • Reduction in markers of inflammation ie TNF, IL-6 [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
  • Improved markers of glycemic control - fructosamine, HOMA [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: February 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Consumption of Dietary Portfolio
    The study involves following an aggressive low fat diet that is high in viscous fiber, nuts and soy protein. The diet is individually tailored to meet individual participants needs.
  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Patients with type II diabetes mellitus
  2. Recently (<5 months) undergone coronary artery bypass graft surgery
  3. Taking cholesterol lowering medication

Exclusion Criteria:

  1. Can not speak English and have no available interpreter
  2. Refuse Informed Consent
  3. Had "off pump" CABG
  4. Are intolerant of statins
  5. Are pre-menopausal (women) or are on HRT
  6. Have serious concomitant disease
  7. Take insulin
  8. Are <18 years of age
  9. receive incomplete revascularization
  10. documented history of drug or alcohol abuse
  11. Intend to become pregnant during study period
  12. Have an unreliable psychological condition that makes them unlikely to comply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462436

Contacts
Contact: Mary Keith, PhD, RD 416-864-5551 keithm@smh.toronto.on.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Mary Keith, PhD, RD            
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Diabetes Association
Investigators
Principal Investigator: Mary Keith, PhD, RD St. Michael's Hospital, Toronto
  More Information

Publications:
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George PB, Tobin KJ, Corpus RA, Devlin WH, O'Neill WW. Treatment of cardiac risk factors in diabetic patients: How well do we follow the guidelines? Am Heart J. 2001 Nov;142(5):857-63.
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Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Lapsley KG, Trautwein EA, Josse RG, Leiter LA, Connelly PW. Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids and C-reactive protein. JAMA. 2003 Jul 23;290(4):502-10.
Jenkins DJ, Wolever TM, Rao AV, Hegele RA, Mitchell SJ, Ransom TP, Boctor DL, Spadafora PJ, Jenkins AL, Mehling C, et al. Effect on blood lipids of very high intakes of fiber in diets low in saturated fat and cholesterol. N Engl J Med. 1993 Jul 1;329(1):21-6.
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Garvey WT, Kwon S, Zheng D, Shaughnessy S, Wallace P, Hutto A, Pugh K, Jenkins AJ, Klein RL, Liao Y. Effects of insulin resistance and type 2 diabetes on lipoprotein subclass particle size and concentration determined by nuclear magnetic resonance. Diabetes. 2003 Feb;52(2):453-62.
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Tepper OM, Galiano RD, Capla JM, Kalka C, Gagne PJ, Jacobowitz GR, Levine JP, Gurtner GC. Human endothelial progenitor cells from type II diabetics exhibit impaired proliferation, adhesion, and incorporation into vascular structures. Circulation. 2002 Nov 26;106(22):2781-6.
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Verma S, Kuliszewski MA, Li SH, Szmitko PE, Zucco L, Wang CH, Badiwala MV, Mickle DA, Weisel RD, Fedak PW, Stewart DJ, Kutryk MJ. C-reactive protein attenuates endothelial progenitor cell survival, differentiation, and function: further evidence of a mechanistic link between C-reactive protein and cardiovascular disease. Circulation. 2004 May 4;109(17):2058-67. Epub 2004 Apr 12.
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Jenkins DJ, Kendall CW, Jackson CJ, Connelly PW, Parker T, Faulkner D, Vidgen E, Cunnane SC, Leiter LA, Josse RG. Effects of high- and low-isoflavone soyfoods on blood lipids, oxidized LDL, homocysteine, and blood pressure in hyperlipidemic men and women. Am J Clin Nutr. 2002 Aug;76(2):365-72.
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Responsible Party: St. Michael's Hospital ( Dr. Mary Keith )
Study ID Numbers: REB06-179C
Study First Received: April 17, 2007
Last Updated: July 16, 2008
ClinicalTrials.gov Identifier: NCT00462436  
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
functional foods
soy
nuts
LDL cholesterol
fibre
secondary prevention
 risk reduction
endothelial function
endothelial progenitor cells
inflammation
glycemic control
HOMA

Study placed in the following topic categories:
Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Ischemia
Arteriosclerosis
 Inflammation
Coronary Disease
Diabetes Mellitus, Type 2
Neoplasm Metastasis
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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