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

Type 2 Diabetes Clinical Trial

— GRC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444899
• Other study ID #: NRA3840020
• Status: Completed
• Phase: N/A
• Start date: March 2007
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre de recherche clinique Étienne-Le Bel du CHUS	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid profile		36 months
Primary	Blood pressure		36 months
Primary	HbA1c		36 months