Type 2 Diabetes Clinical Trial
— GRCOfficial title:
Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients
NCT number | NCT00444899 |
Other study ID # | NRA3840020 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2007 |
Est. completion date | December 31, 2018 |
Verified date | April 2019 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - HbA1c > 7% - More than 2 follow-up visits |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche clinique Étienne-Le Bel du CHUS | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke | Pfizer |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lipid profile | 36 months | ||
Primary | Blood pressure | 36 months | ||
Primary | HbA1c | 36 months |
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