Clinical Trials Directory

Trials / Completed

CompletedNCT00444899

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

Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
101 (actual)
Sponsor
Université de Sherbrooke · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALIntensive treatmentSubjects 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.
OTHERNormal follow-upSubject will continue to be followed by their endocrinologist and general practitioner as they already do.

Timeline

Start date
2007-03-01
Primary completion
2013-12-01
Completion
2018-12-31
First posted
2007-03-08
Last updated
2019-05-01

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00444899. Inclusion in this directory is not an endorsement.