Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Type 2 Diabetes Patients

NCT ID: NCT00444899

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2018-12-31

Brief Summary

Worldwide, health systems and practitioners are facing obesity epidemics. High blood pressure, dyslipidemia and diabetes prevalence will explode during the 21st century.

The two main objectives of this 2-year controlled prospective study are:

1. to demonstrate that, for patients with high blood pressure, diabetes and dyslipidemia, dietician conducted survey and management in combination with annual endocrinologist follow-up enable both attainment and maintenance of recommended blood pressure, glycemic and lipid goals, as well as smoking cessation;

2. to demonstrate that dietician management is more cost effective than conventional care provided by general practitioners and endocrinologists.

Results are expected to show significantly different cardiovascular risk profiles (BMI and waist circumference, systolic and diastolic blood pressure, LDL-C, triglycerides and Total cholesterol/HDL ratio, HbA1c, smoking) between baseline and after 2 years follow-up. Sample size was determined in order to show statistically significant differences between the two groups.

Results will document for the benefit of care givers, health economists and policy makers alike an innovative and integrated model of care which is expected to be effective at the patient level as well as cost effective with respect to the increasing financial burden of diabetes on the health system.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive treatment

Submitted to an intensive follow-up by the dietician.

Group Type: EXPERIMENTAL

Intensive treatment

Intervention Type: BEHAVIORAL

Subjects will be followed by the dietician in combination with his/her endocrinologist. Diet, physical activity, smoking cessation and drug prescriptions will be used to treat subjects.

Usual treatment

Subjects will remain under the care of their endocrinologist and/or general practitioner.

Group Type: ACTIVE_COMPARATOR

Normal follow-up

Intervention Type: OTHER

Subject will continue to be followed by their endocrinologist and general practitioner as they already do.

Interventions

Intensive treatment

Subjects will be followed by the dietician in combination with his/her endocrinologist. Diet, physical activity, smoking cessation and drug prescriptions will be used to treat subjects.

Intervention Type: BEHAVIORAL

Normal follow-up

Subject will continue to be followed by their endocrinologist and general practitioner as they already do.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• HbA1c > 7%
• More than 2 follow-up visits

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

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Jean-Luc Ardilouze

Endocrinologist, researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrice Perron, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Centre de recherche clinique Étienne-Le Bel du CHUS

Sherbrooke, Quebec, Canada

Countries

Canada

Study Documents

Document Type: Clinical Study Report

View Document

Other Identifiers

NRA3840020

Identifier Type: -

Identifier Source: org_study_id