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Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy

This study has been completed.
Sponsor:
Collaborators:
Roche Pharma Deutschland GmbH, Grenzach-Wyhlen, Germany
Institute for Medical Outcom Research GmbH, Loerrach, Germany
Information provided by:
DiaNe HCM GmbH
ClinicalTrials.gov Identifier:
NCT00782847
First received: October 30, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathy
 Behavioral: DiaNe consultation and support program
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DiaNe HCM GmbH:

Primary Outcome Measures:
  • deterioration of kidney function in diabetic nephropathy [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: July 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: with DiaNe program
study subjects which participated in the DiaNe consultation and support program
 Behavioral: DiaNe consultation and support program
the DiaNe consultation and support program for clients with diabetic nephropathy consists of 4 sessions at 90-120 minutes conducted every week in a period of 4 weeks
Other Name: DiaNe program, DiaNe(R)
No Intervention: without DiaNe program
study subjects which received standard care by diabetologist and/or nephrologist

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782847

Locations
Germany
Diabetes- und Nierenzentrum Dormagen
Dormagen, NRW, Germany, D-41539
Sponsors and Collaborators
DiaNe HCM GmbH
Roche Pharma Deutschland GmbH, Grenzach-Wyhlen, Germany
Institute for Medical Outcom Research GmbH, Loerrach, Germany
Investigators
Principal Investigator: Ludwig F Merker, MD Diabetes- und Nierenzentrum Dormagen
  More Information

No publications provided

Responsible Party: Ludwig Merker, MD, Diabetes- und Nierenzentrum Dormagen
ClinicalTrials.gov Identifier: NCT00782847     History of Changes
Other Study ID Numbers: DiaNe-Studie
Study First Received: October 30, 2008
Last Updated: October 30, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by DiaNe HCM GmbH:
diabetes mellitus
diabetic nephropathy
hypertension

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diane
Cyproterone
Cyproterone Acetate
Androgen Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 23, 2013