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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Intensive treatment
* Other: Normal follow-up


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive treatment<br>Submitted to an intensive follow-up by the dietician. | Behavioral: Intensive treatment<br>* 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.<br>|
| Active Comparator: Usual treatment<br>Subjects will remain under the care of their endocrinologist and/or general practitioner. | Other: Normal follow-up<br>* Subject will continue to be followed by their endocrinologist and general practitioner as they already do.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile |  | 36 months | 
| Blood pressure |  | 36 months | 
| HbA1c |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive treatment, dietician