Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Type 2 Diabetes Patients (GRC)
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|ClinicalTrials.gov Identifier: NCT00444899|
Recruitment Status : Active, not recruiting
First Posted : March 8, 2007
Last Update Posted : May 8, 2018
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:
- 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;
- 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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Lipid profile [ Time Frame: 36 months ]
- Blood pressure [ Time Frame: 36 months ]
- HbA1c [ Time Frame: 36 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00444899
|Centre de recherche clinique Étienne-Le Bel du CHUS|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Patrice Perron, MD, MSc||Université de Sherbrooke|