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

History of Changes

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:

MedlinePlus related topics: Cholesterol Coronary Artery Disease Diabetes Diabetes Type 2 Dietary Fiber

U.S. FDA Resources

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:

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:

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

Exclusion Criteria:

Can not speak English and have no available interpreter
Refuse Informed Consent
Had "off pump" CABG
Are intolerant of statins
Are pre-menopausal (women) or are on HRT
Have serious concomitant disease
Take insulin
Are <18 years of age
receive incomplete revascularization
documented history of drug or alcohol abuse
Intend to become pregnant during study period
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

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:

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Morricone L, Ranucci M, Denti S, Cazzaniga A, Isgro G, Enrini R, Caviezel F. Diabetes and complications after cardiac surgery: comparison with a non-diabetic population. Acta Diabetol. 1999 Jun;36(1-2):77-84.

Carson JL, Scholz PM, Chen AY, Peterson ED, Gold J, Schneider SH. Diabetes mellitus increases short-term mortality and morbidity in patients undergoing coronary artery bypass graft surgery. J Am Coll Cardiol. 2002 Aug 7;40(3):418-23.

Schwartz L, Kip KE, Frye RL, Alderman EL, Schaff HV, Detre KM. Coronary bypass graft patency in patients with diabetes in the Bypass Angioplasty Revascularization Investigation (BARI). Circulation. 2002 Nov 19;106(21):2652-8.

[No authors listed] The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary-artery bypass grafts. The Post Coronary Artery Bypass Graft Trial Investigators. N Engl J Med. 1997 Jan 16;336(3):153-62. Erratum in: N Engl J Med 1997 Dec 18;337(25):1859.

Pearson TA, Peters TD. The treatment gap in coronary artery disease and heart failure: community standards and the post-discharge patient. Am J Cardiol. 1997 Oct 30;80(8B):45H-52H. Review.

EUROASPIRE I and II Group; European Action on Secondary Prevention by Intervention to Reduce Events. Clinical reality of coronary prevention guidelines: a comparison of EUROASPIRE I and II in nine countries. EUROASPIRE I and II Group. European Action on Secondary Prevention by Intervention to Reduce Events. Lancet. 2001 Mar 31;357(9261):995-1001.

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McFarlane SI, Jacober SJ, Winer N, Kaur J, Castro JP, Wui MA, Gliwa A, Von Gizycki H, Sowers JR. Control of cardiovascular risk factors in patients with diabetes and hypertension at urban academic medical centers. Diabetes Care. 2002 Apr;25(4):718-23.

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.

Hiss RG, Anderson RM, Hess GE, Stepien CJ, Davis WK. Community diabetes care. A 10-year perspective. Diabetes Care. 1994 Oct;17(10):1124-34.

Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004 Jul 13;110(2):227-39.

Ridker PM. Clinical application of C-reactive protein for cardiovascular disease detection and prevention. Circulation. 2003 Jan 28;107(3):363-9. Review. No abstract available.

Ooi M, Cooper A, Lloyd G, Jackson G. A study of lipid profile before and after coronary artery bypass grafting. Br J Clin Pract. 1996 Dec;50(8):433-5.

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.

Bingham SA, Gill C, Welch A, Day K, Cassidy A, Khaw KT, Sneyd MJ, Key TJ, Roe L, Day NE. Comparison of dietary assessment methods in nutritional epidemiology: weighed records v. 24 h recalls, food-frequency questionnaires and estimated-diet records. Br J Nutr. 1994 Oct;72(4):619-43.

Goldberg GR, Black AE, Jebb SA, Cole TJ, Murgatroyd PR, Coward WA, Prentice AM. Critical evaluation of energy intake data using fundamental principles of energy physiology: 1. Derivation of cut-off limits to identify under-recording. Eur J Clin Nutr. 1991 Dec;45(12):569-81. Review.

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Anderson JW, Bridges SR. Dietary fiber content of selected foods. Am J Clin Nutr. 1988 Mar;47(3):440-7.

Fagerberg B, Hulthe J, Bokemark L, Wikstrand J. Low-density lipoprotein particle size, insulin resistance, and proinsulin in a population sample of 58-year-old men. Metabolism. 2001 Jan;50(1):120-4.

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.

Lamarche B, St-Pierre AC, Ruel IL, Cantin B, Dagenais GR, Despres JP. A prospective, population-based study of low density lipoprotein particle size as a risk factor for ischemic heart disease in men. Can J Cardiol. 2001 Aug;17(8):859-65.

St-Pierre AC, Ruel IL, Cantin B, Dagenais GR, Bernard PM, Despres JP, Lamarche B. Comparison of various electrophoretic characteristics of LDL particles and their relationship to the risk of ischemic heart disease. Circulation. 2001 Nov 6;104(19):2295-9.

Krauss RM. Dense low density lipoproteins and coronary artery disease. Am J Cardiol. 1995 Feb 23;75(6):53B-57B. Review.

Williams PT, Haskell WL, Vranizan KM, Krauss RM. The associations of high-density lipoprotein subclasses with insulin and glucose levels, physical activity, resting heart rate, and regional adiposity in men with coronary artery disease: the Stanford Coronary Risk Intervention Project baseline survey. Metabolism. 1995 Jan;44(1):106-14.

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Asahara T, Masuda H, Takahashi T, Kalka C, Pastore C, Silver M, Kearne M, Magner M, Isner JM. Bone marrow origin of endothelial progenitor cells responsible for postnatal vasculogenesis in physiological and pathological neovascularization. Circ Res. 1999 Aug 6;85(3):221-8.

Takahashi T, Kalka C, Masuda H, Chen D, Silver M, Kearney M, Magner M, Isner JM, Asahara T. Ischemia- and cytokine-induced mobilization of bone marrow-derived endothelial progenitor cells for neovascularization. Nat Med. 1999 Apr;5(4):434-8.

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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.

Schachinger V, Britten MB, Zeiher AM. Prognostic impact of coronary vasodilator dysfunction on adverse long-term outcome of coronary heart disease. Circulation. 2000 Apr 25;101(16):1899-906.

Anderson TJ, Uehata A, Gerhard MD, Meredith IT, Knab S, Delagrange D, Lieberman EH, Ganz P, Creager MA, Yeung AC, et al. Close relation of endothelial function in the human coronary and peripheral circulations. J Am Coll Cardiol. 1995 Nov 1;26(5):1235-41.

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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, Marchie A, Parker TL, Connelly PW, Qian W, Haight JS, Faulkner D, Vidgen E, Lapsley KG, Spiller GA. Dose response of almonds on coronary heart disease risk factors: blood lipids, oxidized low-density lipoproteins, lipoprotein(a), homocysteine, and pulmonary nitric oxide: a randomized, controlled, crossover trial. Circulation. 2002 Sep 10;106(11):1327-32.

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.

Jenkins DJ, Kendall CW, Augustin LS, Martini MC, Axelsen M, Faulkner D, Vidgen E, Parker T, Lau H, Connelly PW, Teitel J, Singer W, Vandenbroucke AC, Leiter LA, Josse RG. Effect of wheat bran on glycemic control and risk factors for cardiovascular disease in type 2 diabetes. Diabetes Care. 2002 Sep;25(9):1522-8.

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 May 19, 2013

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