Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306436
Status:
UNKNOWN
Last Update Posted:
2007-06-13
First Post:
2006-03-21
Brief Title:
Comprehensive Management of Diabetic Patients With Renal Impairment Impact on Blood Pressure and Glycemic Control
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Evaluation of the Impact of a Comprehensive Clinical Management on the Quality of Blood Pressure and Glycemic Control in Diabetic Uremic Patients
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 mLmin173 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 mlmin every 4 months if the GFR is between 40 and 20 mlmin and every 1 or 2 months if the GFR is under 20 mlmin 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 13585 mmHg and 12575 mmHg if proteinuria 1g24H 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 patients 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 beforeafter the intervention
If validated this strategy may provide the basis of a care network focused on an optimum diabetic health care
Our project aims at evaluating a comprehensive management approach of diabetic patients affected by renal insufficiency defined by glomerular filtration rate GRF 60 mLmin173 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 mlmin every 4 months if the GFR is between 40 and 20 mlmin and every 1 or 2 months if the GFR is under 20 mlmin 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 13585 mmHg and 12575 mmHg if proteinuria 1g24H 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 patients 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 beforeafter the intervention
If validated this strategy may provide the basis of a care network focused on an optimum diabetic health care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2001-027 | None | None | None |