Clinical trial NCT00306436: Comprehensive Management of Diabetic Patients With Renal Impairment : Impact on Blood Pressure and Glycemic Control
Official title: Evaluation of the Impact of a Comprehensive Clinical Management on the Quality of Blood Pressure and Glycemic Control in Diabetic Uremic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Nephropathies
Keywords: Diabetes
renal deficiency
hypertension
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2006-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diabetic patients affected by renal insufficiency defined by glomerular filtration rate \< 60 ml/min/1,73 m² by the Cockcroft-Gault formula
* signed informed consent

Exclusion Criteria:

* pregnant woman
* minors

Primary outcomes:
measure: composite criteria reflecting a good glycemic and arterial pressure status. Success defined by all measurements of HbA1c < 6.5% and of systolic (diastolic) pressure <=135 (85) mmHg if proteinuria is < 1g/24h or <= 125 (75) if proteinuria is => 1g/24h
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux cedex
country: France
facility: Service de Néphrologie-Hémodialyse du Pr C.Combe, Hôpital Pellegrin, Place Amélie Raba-Léon
Study officials:
affiliation: University Hospital, Bordeaux
name: Catherine Lasseur, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Geneviève Chêne, Professor
role: STUDY_CHAIR
References: