Clinical trial NCT00782847: Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy
Official title: A Prospective Controlled Randomized Multicenter Trial to Evaluate the Effect of a Structurized Multifactorial Behavior Modifying Consultation and Support Programme DiaNe for People With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Nephropathy
Keywords: diabetes mellitus
diabetic nephropathy
hypertension
Lead sponsor: DiaNe HCM GmbH
Sponsor class: OTHER
Collaborators: name: Roche Pharma Deutschland GmbH, Grenzach-Wyhlen, Germany
name: Institute for Medical Outcom Research GmbH, Loerrach, Germany
First posted: 2008-10-31
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designated to evaluate the effect of a patients' educational program called DiaNe® for consultation and support people with diabetic kidney disease in an early stage. The aim of the study is to examine if the program is suitable to stop deterioration of kidney function and to maintain or improve glycemic control. The consultation and support program DiaNe® substantially contributes to a better understanding of the affected clients for this complex clinical picture, allows them for specific interventions and creates the rationale for an active therapeutic relationship.

Detailed description: According to statistics diabetes mellitus is considered to be the leading cause for end stage renal disease in Germany, approximately 35% of the patients starting on dialysis are affected by diabetes-induced nephropathy. This can be seen in countries all over the world. This situation has been known for years. To date, neither structured intervention methods nor educational programs have been designed for and targeting those affected, which would consequently allow for structured, multifactorial intervention at an early stage of diabetic nephropathy. Multifactorial interventions, as published in the Steno-2 trial, appear to be highly effective with regard to long-term complications of diabetes. In order to realize this approach for the affected as well as the medical staff caring for patients with diabetes-induced nephropathy we developed DiaNe®, a consultation and support program, which is designed to give detailed information to the affected in order to induce behavioral changes. We were able to show a clinically significant reduction of microalbuminuria within a first monocenter evaluation trial. We wanted to verify this effect by means of a prospective multicenter randomized cohort trial according to GCP-ICH guidelines.

Eligibility criteria: Inclusion Criteria:

* diabetes mellitus
* proven diabetic nephropathy by histological/lab findings and/or discretion of nephrologist
* ability to understand the German language

Exclusion Criteria:

* end stage renal disease and/or dialysis
* unable or unwilling to follow the protocol
* pregnant women
* discretion of nephrologist

Primary outcomes:
measure: deterioration of kidney function in diabetic nephropathy
timeFrame: 13 months
Secondary outcomes:
measure: HbA1c
timeFrame: 13 months
Other outcomes:
Locations:
city: Dormagen
country: Germany
facility: Diabetes- und Nierenzentrum Dormagen
state: NRW
Study officials:
affiliation: Diabetes- und Nierenzentrum Dormagen
name: Ludwig F Merker, MD
role: PRINCIPAL_INVESTIGATOR
References: