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

NCT00444899 | Completed

• 1 other identifier: NRA3840020
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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. 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. 2.to demonstrate that dietician management is more cost effective than conventional care provided by general practitioners and endocrinologists.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Intensive treatment; dietician

Outcome Measures

Primary Outcomes (3)

• Lipid profile

  36 months

• Blood pressure

  36 months

• HbA1c

  36 months

Study Arms (2)

Intensive treatment

EXPERIMENTAL

Submitted to an intensive follow-up by the dietician.

Behavioral: Intensive treatment

Usual treatment

ACTIVE COMPARATOR

Subjects will remain under the care of their endocrinologist and/or general practitioner.

Other: Normal follow-up

Interventions

Intensive treatment BEHAVIORAL

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.

Intensive treatment

Normal follow-up OTHER

Subject will continue to be followed by their endocrinologist and general practitioner as they already do.

Usual treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HbA1c \> 7%
• More than 2 follow-up visits

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Pfizer: collaborator

Study Sites (1)

Centre de recherche clinique Étienne-Le Bel du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Patrice Perron, MD, MSc

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist, researcher

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 31, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)