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Management of Diabetes Mellitus Patients With Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00828425
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : August 18, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:

Aim of this NIS is to retrospectively document the management of diabetic patients with retinopathy in a naturalistic setting in Switzerland. Following elements are going to be analyzed:

  • which medication are used to keep blood pressure under control?
  • which medication are used for metabolic control?
  • the average control level of metabolism and blood pressure is compliant with the international guidelines?
  • laser photocoagulation plays a role in the control of metabolism and blood pressure?
  • there are differences in the control of metabolism and blood pressure between patients with DM I or DM II?
  • there is an influence of renal failure on the choose of medication?

Condition or disease
Retinopathy Diabetes Mellitus

Study Design

Study Type : Observational
Estimated Enrollment : 2500 participants
Time Perspective: Retrospective
Official Title: Management of Diabetes Mellitus Patients With Retinopathy
Study Start Date : December 2008
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Diabetic patients with retinopathy


Outcome Measures

Primary Outcome Measures :
  1. Blood lipids, glycemia, HbA1C, blood creatinine, proteinuria, body weight [ Time Frame: every 3 months ]
  2. evolution of diabetic retinopathy [ Time Frame: every 3 months ]

Secondary Outcome Measures :
  1. concomitant medication [ Time Frame: every 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetic patients with diabetic retinopathy
Criteria

Inclusion Criteria:

  • Diabetic patients
  • Diabetic retinopathy
Contacts and Locations

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): NCT00828425


  Show 62 Study Locations
Sponsors and Collaborators
AstraZeneca
More Information

Responsible Party: Dr. Med. Dirk Schneider - Medical Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00828425     History of Changes
Other Study ID Numbers: NIS-CCH-DUM-2008/1
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: August 18, 2010
Last Verified: August 2010

Keywords provided by AstraZeneca:
Diabetes Mellitus
retinopathy
Management of diabetic patients with retinopathy

Additional relevant MeSH terms:
Diabetes Mellitus
Retinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases