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

Université de Sherbrooke

Status: Completed

Conditions: Type 1 Diabetes; Type 2 Diabetes

Treatments: Behavioral: Intensive treatment; Other: Normal follow-up

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00444899

NRA3840020

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Intensive treatment

Experimental group

Description:

Submitted to an intensive follow-up by the dietician.

Treatment:

Behavioral: Intensive treatment

Usual treatment

Active Comparator group

Description:

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

Treatment:

Other: Normal follow-up