Comparison of 4 Diets in the Management of Overweight Patients With Vascular Disease

NCT ID: NCT00229229

Last Updated: 2009-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-01-31

Brief Summary

Type 2 diabetes can be prevented by lifestyle changes in high-risk subjects. However, controversies exist on nutritional management of diabetes. Recent data suggests that glucose and insulin responses are affected by not only the quality, but the quantity of carbohydrate consumed. This is referred to as glycemic load.

To date, there have not been any prospective randomized studies which examine the utility of a low glycemic load diet.

The purpose of the proposed study is to compare the effectiveness of a Canada Food Guide Diet with a low glycemic load diet on blood sugar control in overweight type 2 diabetics.

Detailed Description

The primary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.

The secondary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease. The purpose of this portion of the study is to try to elucidate the relative contributions of the glycemic index and carbohydrate content to the overall effectiveness of a low glycemic load diet. Furthermore, through detailed analysis of actual dietary consumption, and correlation with subsequent weight loss, we hope to gain greater insight into the role of compliance on the success of the various dietary strategies. Restriction of caloric intake is necessary for weight loss regardless of the dietary strategy employed, however, long-term success depends ultimately on the ability of the patients to comply with the said diet. The success of a low glycemic load diet may lie in its superior effectiveness (greater compliance, less calorie consumption) rather than a greater efficacy per se.

A secondary analysis of the effects of all three diets (low glycemic load, low glycemic index and low carbohydrate) on modifying other metabolic factors will also be performed. In particular, the study will examine the effect of the three diets on lipid and fat metabolism, insulin resistance and inflammation.

Conditions

Obesity; Cardiovascular Disease; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Low glycemic load diet

Group Type: OTHER

Low glycemic load diet

Intervention Type: OTHER

A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

2

Canada Food Guide Diet

Group Type: OTHER

Canada Food Guide Diet

Intervention Type: OTHER

A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

3

Low glycemic index diet

Group Type: OTHER

Low glycemic index diet

Intervention Type: OTHER

A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

4

Low carbohydrate diet

Group Type: OTHER

Low carbohydrate diet

Intervention Type: OTHER

A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

Interventions

Low glycemic load diet

A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

Intervention Type: OTHER

Canada Food Guide Diet

A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

Intervention Type: OTHER

Low glycemic index diet

A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

Intervention Type: OTHER

Low carbohydrate diet

A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women, aged 18 to 80 years
• BMI 25-40 kg/m2
• Documented Cardiovascular Disease as evidenced by one or more of the following:

• Coronary atherosclerosis during coronary angiography
• Documented myocardial infarction
• Carotid atherosclerosis during carotid ultrasonography
• Carotid atherosclerosis during CT angiography
• Carotid atherosclerosis during MR angiography
• Ischemic brain infarct documented on brain imaging studies

Exclusion Criteria

• Documented Type I or II diabetes mellitus (as defined by the Canadian Diabetes Association 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada)
• Previous (<5 years ago) individual or group dietary counseling with a registered dietician
• Pregnant or lactating women
• Presence of clinically important hepatic or renal disease
• Inability to communicate effectively using the English language
• Enrollment in another study concurrently
• Inability to give informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

QUEEN'S UNIVERSITY

Principal Investigators

Stephen A LaHaye, MD

Role: PRINCIPAL_INVESTIGATOR

Vascular Disease Prevention and Research Centre

Locations

Vascular Disease Prevention and Research Centre

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

DMED-793-04

Identifier Type: -

Identifier Source: org_study_id