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| Sponsors and Collaborators: |
DiaNe HCM GmbH 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 |
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 III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| 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 |
| 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 |
|---|---|
|
with DiaNe program: Active Comparator
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
|
|
without DiaNe program: No Intervention
study subjects which received standard care by diabetologist and/or nephrologist
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany, NRW | |
| Diabetes- und Nierenzentrum Dormagen | |
| Dormagen, NRW, Germany, D-41539 | |
| Principal Investigator: | Ludwig F Merker, MD | Diabetes- und Nierenzentrum Dormagen |
More Information
| Responsible Party: | Diabetes- und Nierenzentrum Dormagen ( Ludwig Merker, MD ) |
| Study ID Numbers: | DiaNe-Studie |
| Study First Received: | October 30, 2008 |
| Last Updated: | October 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00782847 History of Changes |
| Health Authority: | Germany: Ethics Commission |
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diabetes mellitus diabetic nephropathy hypertension |
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Diabetic Nephropathies Hormone Antagonists Cyproterone Acetate Hormones, Hormone Substitutes, and Hormone Antagonists Diabetes Mellitus Cyproterone Endocrine System Diseases Hormones |
Androgen Antagonists Urologic Diseases Kidney Diseases Endocrinopathy Diane Diabetes Complications Hypertension Androgens |
|
Androgen Antagonists Diabetic Nephropathies Urologic Diseases Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Diabetes Mellitus Endocrine System Diseases Kidney Diseases Diane Pharmacologic Actions Diabetes Complications |
