Type 1 DiabetesGRCNCT00444899
Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Type 2 Diabetes Patients
A study testing Intensive treatment and Normal follow-up in people with Type 1 Diabetes and Type 2 Diabetes, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Intensive treatment and Normal follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c > 7%
- More than 2 follow-up visits
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche clinique Étienne-Le Bel du CHUS
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients
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:
Read more
- 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.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Intensive treatment, Normal follow-up
- Keywords
- Intensive treatment, dietician
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive treatmentBehavioural
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.
Normal follow-upOther
Subject will continue to be followed by their endocrinologist and general practitioner as they already do.
| Study group | Role | What they receive |
|---|---|---|
| Intensive treatment | Experimental | Submitted to an intensive follow-up by the dietician. Receives: Behavioral: Intensive treatment |
| Usual treatment | Active comparator | Subjects will remain under the care of their endocrinologist and/or general practitioner. Receives: Other: Normal follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Measured: 36 months
Blood pressure
Measured: 36 months
HbA1c
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2013
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Jean-Luc Ardilouze, Université de Sherbrooke
- Investigators
- Patrice Perron, MD, MSc, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444899
- Sponsor's protocol ID
- NRA3840020
- Acronym
- GRC
- Status last verified
- Apr 2019
- First submitted
- 7 Mar 2007
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients
- ClinicalTrials.gov ID
- NCT00444899
- Acronym / sponsor ID
- GRC / NRA3840020
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Intensive treatment, dietician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2007 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive treatment | Experimental | Behavioral: Intensive treatmentSubmitted to an intensive follow-up by the dietician. |
| Usual treatment | Active comparator | Other: Normal follow-upSubjects will remain under the care of their endocrinologist and/or general practitioner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HbA1c > 7%
- More than 2 follow-up visits
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive treatmentSubjects 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. | Behavioural | Intensive treatment |
| Normal follow-upSubject will continue to be followed by their endocrinologist and general practitioner as they already do. | Other | Usual treatment |
Primary outcome
Lipid profile
Time frame: 36 months
Blood pressure
Time frame: 36 months
HbA1c
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Perron, MD, MSc principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive treatment and Normal follow-up in people with Type 1 Diabetes and Type 2 Diabetes, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.