Innovative Strategies For Risk Reduction Following CABG

This study has been completed.
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00462436
First received: April 17, 2007
Last updated: July 21, 2010
Last verified: February 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Do Innovative Strategies Complement Medical Management to Reduce Cardiovascular Risk Factors Following Coronary Artery Bypass Graft Surgery?

Resource links provided by NLM:


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
Study Completion Date: May 2010
Primary Completion Date: December 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462436

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
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:
25. The Agricultural Research Service. Composition of Foods, Agriculture Handbook No 8. Washington, DC, US Department of Agriculture, 1992.

Responsible Party: Dr. Mary Keith, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00462436     History of Changes
Other Study ID Numbers: REB06-179C
Study First Received: April 17, 2007
Last Updated: July 21, 2010
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014