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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444899
Recruitment Status : Active, not recruiting
First Posted : March 8, 2007
Last Update Posted : May 8, 2018
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Université de Sherbrooke

Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Behavioral: Intensive treatment Other: Normal follow-up Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients
Study Start Date : March 2007
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Lipid profile [ Time Frame: 36 months ]
  2. Blood pressure [ Time Frame: 36 months ]
  3. HbA1c [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444899

Canada, Quebec
Centre de recherche clinique Étienne-Le Bel du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Principal Investigator: Patrice Perron, MD, MSc Université de Sherbrooke

Study Data/Documents: Clinical Study Report  This link exits the site

Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Université de Sherbrooke Identifier: NCT00444899     History of Changes
Other Study ID Numbers: NRA3840020
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jean-Luc Ardilouze, Université de Sherbrooke:
Intensive treatment

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