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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00444899
First received: March 7, 2007
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Type 2 Diabetes
 Behavioral: Intensive treatment
Other: Normal follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:
  • Lipid profile [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2007
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive treatment
Submitted to an intensive follow-up by the dietician.
 Behavioral: 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: Usual treatment
Subjects will remain under the care of their endocrinologist and/or general practitioner.
 Other: Normal follow-up
Subject will continue to be followed by their endocrinologist and general practitioner as they already do.

  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

Locations
Canada, Quebec
Centre de recherche clinique Étienne-Le Bel du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Universitaire de Sherbrooke
Pfizer
Investigators
Principal Investigator: Patrice Perron, MD, MSc Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT00444899     History of Changes
Other Study ID Numbers: NRA3840020
Study First Received: March 7, 2007
Last Updated: November 17, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Universitaire de Sherbrooke:
Intensive treatment
dietician

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013