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

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NCT00444899

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Study Location
Centre de recherche clinique Étienne-Le Bel du CHUS
Sherbrooke, Quebec, J1H 5N4, Canada
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 1 Diabetes, Type 2 Diabetes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- HbA1c > 7%

- More than 2 follow-up visits

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Type 1 Diabetes, Type 2 DiabetesClinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Type 2 Diabetes Patients
NCT00444899
  1. Sherbrooke, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Type 2 Diabetes Patients
Official Title  ICMJE Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 1 Diabetes
  • Type 2 Diabetes
Intervention  ICMJE
  • 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.
  • Other: Normal follow-up
    Subject will continue to be followed by their endocrinologist and general practitioner as they already do.
Study Arms  ICMJE
  • Experimental: Intensive treatment
    Submitted to an intensive follow-up by the dietician.
    Intervention: Behavioral: Intensive treatment
  • Active Comparator: Usual treatment
    Subjects will remain under the care of their endocrinologist and/or general practitioner.
    Intervention: Other: Normal follow-up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2019)		101
Original Enrollment  ICMJE
 (submitted: March 7, 2007)		80
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HbA1c > 7%
  • More than 2 follow-up visits
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00444899
Other Study ID Numbers  ICMJE NRA3840020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Jean-Luc Ardilouze, Université de Sherbrooke
Study Sponsor  ICMJE Université de Sherbrooke
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Patrice Perron, MD, MScUniversité de Sherbrooke
PRS Account Université de Sherbrooke
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP