Overview

This trial is active, not recruiting.

Conditions type 1 diabetes, type 2 diabetes
Treatments intensive treatment, normal follow-up
Sponsor Université de Sherbrooke
Collaborator Pfizer
Start date March 2007
End date December 2013
Trial size 80 participants
Trial identifier NCT00444899, NRA3840020

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Submitted to an intensive follow-up by the dietician.
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.
(Active Comparator)
Subjects will remain under the care of their endocrinologist and/or general practitioner.
normal follow-up
Subject will continue to be followed by their endocrinologist and general practitioner as they already do.

Primary Outcomes

Measure
Lipid profile
time frame: 36 months
Blood pressure
time frame: 36 months
HbA1c
time frame: 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - HbA1c > 7% - More than 2 follow-up visits

Additional Information

Official title Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients
Principal investigator Patrice Perron, MD, MSc
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Université de Sherbrooke.