NCT00306436

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 13, 2007

Status Verified

June 1, 2007

First QC Date

March 21, 2006

Last Update Submit

June 12, 2007

Conditions

Diabetic Nephropathies

Keywords

Diabetesrenal deficiencyhypertension

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

comprehensive managementPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnant woman
  • minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Néphrologie-Hémodialyse du Pr C.Combe, Hôpital Pellegrin, Place Amélie Raba-Léon

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Catherine Lasseur, Doctor

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Geneviève Chêne, Professor

    University Hospital, Bordeaux

    STUDY CHAIR

Central Study Contacts

Catherine Lasseur, doctor

CONTACT

33 (0) 5 56 79 55 37catherine.lasseur@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 23, 2006

Study Start

May 1, 2006

Study Completion

May 1, 2008

Last Updated

June 13, 2007

Record last verified: 2007-06

Locations

FR(1)