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

NCT00229229 | Terminated Phase 4 DMC

• 1 other identifier: DMED-793-04
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Cardiovascular Disease; Metabolic Syndrome

Keywords

Obesity; Cardiovascular Disease; Metabolic Syndrome; Canada Food Guide; Glycemic Index; Glycemic Load

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• 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.

  1 year

Study Arms (4)

1

OTHER

Low glycemic load diet

Other: Low glycemic load diet

2

OTHER

Canada Food Guide Diet

Other: Canada Food Guide Diet

3

OTHER

Low glycemic index diet

Other: Low glycemic index diet

4

OTHER

Low carbohydrate diet

Other: Low carbohydrate diet

Interventions

Low glycemic load diet OTHER

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

1

Canada Food Guide Diet OTHER

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

2

Low glycemic index diet OTHER

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

3

Low carbohydrate diet OTHER

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

4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Vascular Disease Prevention and Research Centre

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases; Metabolic Syndrome

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Stephen A LaHaye, MD

  Vascular Disease Prevention and Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 29, 2005
• Study Start: September 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

CA (1)