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Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy (DiaNe)

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ClinicalTrials.gov Identifier: NCT00782847
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : October 31, 2008
Roche Pharma Deutschland GmbH, Grenzach-Wyhlen, Germany
Institute for Medical Outcom Research GmbH, Loerrach, Germany
Information provided by:
DiaNe HCM GmbH

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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Behavioral: DiaNe consultation and support program Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2004
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. deterioration of kidney function in diabetic nephropathy [ Time Frame: 13 months ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 13 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782847

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
Principal Investigator: Ludwig F Merker, MD Diabetes- und Nierenzentrum Dormagen

Responsible Party: Ludwig Merker, MD, Diabetes- und Nierenzentrum Dormagen
ClinicalTrials.gov Identifier: NCT00782847     History of Changes
Other Study ID Numbers: DiaNe-Studie
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: October 31, 2008
Last Verified: October 2008

Keywords provided by DiaNe HCM GmbH:
diabetes mellitus
diabetic nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Cyproterone acetate, ethinyl estradiol drug combination
Cyproterone Acetate
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents