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Sponsors and Collaborators: |
University Hospital, Bordeaux Ministry of Health, France |
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Information provided by: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00306436 |
Diabetes is the leading cause of end-stage renal disease in developed countries. Hypertension and metabolic control are known to affect the progression of renal deficiency and patient's outcome. Our project aims at implementing a multidisciplinary and systematic approach of diabetic patients with renal deficiency, and at evaluating the impact of metabolic and blood pressure targets as recommended by current guidelines.
Condition | Intervention |
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Diabetic Nephropathies |
Procedure: comprehensive management |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Evaluation of the Impact of a Comprehensive Clinical Management on the Quality of Blood Pressure and Glycemic Control in Diabetic Uremic Patients |
Estimated Enrollment: | 100 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | May 2008 |
Complications of diabetes are influenced by the quality of blood pressure control and of metabolic control.
Several prospective studies have shown a positive effect of the implementation of such control, however metabolic and blood pressure targets are not achieved for about 30% of diabetic uremic patients.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Catherine Lasseur, doctor | 33 (0) 5 56 79 55 37 | catherine.lasseur@chu-bordeaux.fr |
France | |
Service de Néphrologie-Hémodialyse du Pr C.Combe, Hôpital Pellegrin, Place Amélie Raba-Léon | Recruiting |
Bordeaux cedex, France, 33076 | |
Contact: Catherine Lasseur, Doctor 33 (0) 5 56 79 55 37 catherine.lasseur@chu-bordeaux.fr |
Principal Investigator: | Catherine Lasseur, Doctor | University Hospital, Bordeaux |
Study Chair: | Geneviève Chêne, Professor | University Hospital, Bordeaux |
Study ID Numbers: | 9286-01, 2001-027 |
Study First Received: | March 21, 2006 |
Last Updated: | June 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00306436 History of Changes |
Health Authority: | France: Ministry of Health |
Diabetes renal deficiency hypertension |
Diabetic Nephropathies Urologic Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Kidney Diseases Diabetes Complications Hypertension |
Diabetic Nephropathies Urologic Diseases Diabetes Mellitus |
Endocrine System Diseases Kidney Diseases Diabetes Complications |