Comprehensive Management of Diabetic Patients With Renal Impairment : Impact on Blood Pressure and Glycemic Control

Diabetic Nephropathies Clinical Trial

Official title:

Evaluation of the Impact of a Comprehensive Clinical Management on the Quality of Blood Pressure and Glycemic Control in Diabetic Uremic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00306436
• Other study ID #: 9286-01
• Secondary ID: 2001-027
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2006
• Last updated: June 12, 2007
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: June 2007
• Source: University Hospital, Bordeaux
• Contact: Catherine Lasseur, doctor
• Phone: 33 (0) 5 56 79 55 37
• Email: catherine.lasseur[@]chu-bordeaux.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetic Nephropathies

Intervention

Procedure:
• comprehensive management

Locations

Country	Name	City	State
France	Service de Néphrologie-Hémodialyse du Pr C.Combe, Hôpital Pellegrin, Place Amélie Raba-Léon	Bordeaux cedex

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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