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Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Type 2 Diabetes Patients (GRC)
This study is currently recruiting participants.
Verified by Universitaire de Sherbrooke, March 2007
First Received: March 7, 2007   No Changes Posted
Sponsors and Collaborators: Universitaire de Sherbrooke
Pfizer
Information provided by: Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT00444899
  Purpose

Worldwide, health systems and practitioners are facing obesity epidemics. High blood pressure (HBP), dyslipidemia and type 2 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 HBP, type 2 diabetes and dyslipidemia, dietician conducted survey and management in combination with annual endocrinologist follow-up enable both attainment and maintenance of recommended BP, 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 (GPs) and endocrinologists.

Results are expected to show significantly different cardiovascular risk profiles (BMI and waist circumference, systolic and diastolic BP, LDL-C, triglycerides (TG) 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.


Condition Intervention
Type 2 Diabetes
Behavioral: diet
Behavioral: physical activity
Behavioral: Smoking cessation
Procedure: Drugs prescriptions

MedlinePlus related topics: Diabetes Diets Quitting Smoking Smoking
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Type 2 Diabetes Patients

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:
  • Lipid profile
  • Blood pressure
  • HbA1c

Estimated Enrollment: 80
Study Start Date: March 2007
Estimated Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444899

Contacts
Contact: Jean-Luc Ardilouze, MD, PhD 819-346-1110 ext 15241 jean-luc.ardilouze@usherbrooke.ca

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Jean-Luc Ardilouze, MD, PhD     819-346-1110 ext 15241     jean-luc.ardilouze@usherbrooke.ca    
Principal Investigator: Jean-Luc Ardilouze, MD, PhD            
Sponsors and Collaborators
Universitaire de Sherbrooke
Pfizer
Investigators
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Centre hospitalier universitaire de Sherbrooke
  More Information

No publications provided

Study ID Numbers: NRA3840020
Study First Received: March 7, 2007
Last Updated: March 7, 2007
ClinicalTrials.gov Identifier: NCT00444899     History of Changes
Health Authority: Canada: Ethics Review Committee

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009