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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by University Hospital, Bordeaux.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00306436
First received: March 21, 2006
Last updated: June 12, 2007
Last verified: June 2007
  Purpose

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
Diabetic Nephropathies
Procedure: comprehensive management

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Impact of a Comprehensive Clinical Management on the Quality of Blood Pressure and Glycemic Control in Diabetic Uremic Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: May 2006
Estimated Study Completion Date: May 2008
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306436

Contacts
Contact: Catherine Lasseur, doctor 33 (0) 5 56 79 55 37 catherine.lasseur@chu-bordeaux.fr

Locations
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   
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Investigators
Principal Investigator: Catherine Lasseur, Doctor University Hospital, Bordeaux
Study Chair: Geneviève Chêne, Professor University Hospital, Bordeaux
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00306436     History of Changes
Other Study ID Numbers: 9286-01, 2001-027
Study First Received: March 21, 2006
Last Updated: June 12, 2007
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Bordeaux:
Diabetes
renal deficiency
hypertension

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014