Comprehensive Management of Diabetic Patients With Renal Impairment : Impact on Blood Pressure and Glycemic Control
NCT ID: NCT00306436
Last Updated: 2007-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2006-05-31
2008-05-31
Brief Summary
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Detailed Description
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Our project aims at evaluating a comprehensive management approach of diabetic patients affected by renal insufficiency, defined by glomerular filtration rate (GRF) \<60 mL/min/1,73 m², through an alternate and complementary follow-up by the nephrologist and the diabetologist.
During a first period (one year), patients are managed as "usually". After this period, the patients will start the multidisciplinary health care during at least two years. They will be followed-up by the diabetologist every 4 months. According to his GFR measured by renal clearance of Cr-EDTA, the patient will be followed-up by the nephrologist every year if the GFR is between 60 and 40 ml/min, every 4 months if the GFR is between 40 and 20 ml/min, and every 1 or 2 months if the GFR is under 20 ml/min. GFR will be re-evaluated every year (Cr-EDTA or Cockcroft-Gault formula) and so medical examination frequency. Guidelines will be applied regarding blood pressure control (objective: \< 135/85 mmHg, and \< 125/75 mmHg if proteinuria \> 1g/24H, choice of drugs, implementation of the treatment...) and glycemic control (current guidelines according to the French Health Technology Information Agency, ANAES). Another important component of the management will be the implementation of nutritional balance and foot care.
Every two years, a detailed nutritional checkup will be planned by the diabetologist and a cardiologic check-up will be planned by the nephrologist during one day in the local nephrology department.
A biobank will be built up after patient's consent. We will assess the impact of this intervention (guidelines application + multidisciplinary methodical and complementary follow-up) in terms of glycemic and blood pressure control.
The percentage of patients who will obtain a good glycemic and blood pressure control will be analysed and compared between the two follow-up period (before/after the intervention).
If validated this strategy may provide the basis of a care network focused on an optimum diabetic health care.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Interventions
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comprehensive management
Eligibility Criteria
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Inclusion Criteria
* signed informed consent
Exclusion Criteria
* minors
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Bordeaux
OTHER
Principal Investigators
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Catherine Lasseur, Doctor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Geneviève Chêne, Professor
Role: STUDY_CHAIR
University Hospital, Bordeaux
Locations
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Service de Néphrologie-Hémodialyse du Pr C.Combe, Hôpital Pellegrin, Place Amélie Raba-Léon
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2001-027
Identifier Type: -
Identifier Source: secondary_id
9286-01
Identifier Type: -
Identifier Source: org_study_id