Management of Diabetes Mellitus Patients With Retinopathy | NCT00828425 | Trialant

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Management of Diabetes Mellitus Patients With Retinopathy | NCT00828425 | Trialant

Studies
Management of Diabetes Mellitus Patients With Retinopathy

NCT00828425

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Aug 18, 2010Estimated

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Retinopathy
Diabetes Mellitus

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT00828425

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

NIS-CCH-DUM-2008/1

Secondary IDs

Not provided

Brief Title

Management of Diabetes Mellitus Patients With Retinopathy

Official Title

Management of Diabetes Mellitus Patients With Retinopathy

Acronym

Not provided

Organization

AstraZenecaINDUSTRY

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Dec 2008

Primary Completion Date

Not provided

Completion Date

Aug 2009Actual

First Submitted Date

Jan 23, 2009

First Submission Date that Met QC Criteria

Jan 23, 2009

First Posted Date

Jan 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2010

Last Update Posted Date

Aug 18, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

AstraZenecaINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

Not provided

Conditions Module

Conditions

Retinopathy
Diabetes Mellitus

Keywords

Diabetes Mellitus
retinopathy
Management of diabetic patients with retinopathy

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Diabetic patients with retinopathy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood lipids, glycemia, HbA1C, blood creatinine, proteinuria, body weight		every 3 months
evolution of diabetic retinopathy		every 3 months

Secondary Outcomes

Measure	Description	Time Frame
concomitant medication		every 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetic patients
Diabetic retinopathy

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Diabetic patients with diabetic retinopathy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Diegten	Basel-Landschaft		Switzerland
Research Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Not provided

Time Perspective

Retrospective

Masking Info

No data available

No data is available for this block.

Laufen

Basel-Landschaft

Switzerland

Research Site

Dättwil

Canton of Aargau

Switzerland

Research Site

Hausen B. Brugg

Canton of Aargau

Switzerland

Research Site

Lenzburg

Canton of Aargau

Switzerland

Research Site

Lupfig

Canton of Aargau

Switzerland

Research Site

Muri

Canton of Aargau

Switzerland

Research Site

Rheinfelden

Canton of Aargau

Switzerland

Research Site

Schinznach Dorf

Canton of Aargau

Switzerland

Research Site

Spreitenbach

Canton of Aargau

Switzerland

Research Site

Basel

Canton of Basel-City

Switzerland

Research Site

Bern

Canton of Bern

Switzerland

Research Site

Moutier

Canton of Bern

Switzerland

Research Site

Unterseen

Canton of Bern

Switzerland

Research Site

Estavayer-le-Lac

Canton of Fribourg

Switzerland

Research Site

Fribourg

Canton of Fribourg

Switzerland

Research Site

Collonge-Bellerive

Canton of Geneva

Switzerland

Research Site

Geneva

Canton of Geneva

Switzerland

Research Site

Le Grand-Saconnex

Canton of Geneva

Switzerland

Research Site

Les Acacias

Canton of Geneva

Switzerland

Research Site

Versoix

Canton of Geneva

Switzerland

Research Site

Alle

Canton of Jura

Switzerland

Research Site

Lucerne

Canton of Lucerne

Switzerland

Research Site

Rothenburg

Canton of Lucerne

Switzerland

Research Site

Le Locle

Canton of Neuchâtel

Switzerland

Research Site

Kerns

Canton of Obwalden

Switzerland

Research Site

Schaffhausen

Canton of Schaffhausen

Switzerland

Research Site

Küssnacht

Canton of Schwyz

Switzerland

Research Site

Tuggen

Canton of Schwyz

Switzerland

Research Site

Oberuzwil

Canton of St. Gallen

Switzerland

Research Site

Rorschach

Canton of St. Gallen

Switzerland

Research Site

Sankt Gallen

Canton of St. Gallen

Switzerland

Research Site

Wangs

Canton of St. Gallen

Switzerland

Research Site

Aigle

Canton of Vaud

Switzerland

Research Site

Bassins

Canton of Vaud

Switzerland

Research Site

Bex

Canton of Vaud

Switzerland

Research Site

Chateau-d'Oex

Canton of Vaud

Switzerland

Research Site

Clarens

Canton of Vaud

Switzerland

Research Site

Eysins

Canton of Vaud

Switzerland

Research Site

Lausanne

Canton of Vaud

Switzerland

Research Site

Nyon

Canton of Vaud

Switzerland

Research Site

Prilly

Canton of Vaud

Switzerland

Research Site

Renens VD

Canton of Vaud

Switzerland

Research Site

Salavaux

Canton of Vaud

Switzerland

Research Site

St-Legier

Canton of Vaud

Switzerland

Research Site

Vevey

Canton of Vaud

Switzerland

Research Site

Bassersdorf

Canton of Zurich

Switzerland

Research Site

Egg

Canton of Zurich

Switzerland

Research Site

Winterthur

Canton of Zurich

Switzerland

Research Site

Ascona

Canton Ticino

Switzerland

Research Site

Locarno

Canton Ticino

Switzerland

Research Site

Lugano

Canton Ticino

Switzerland

Research Site

Viganello

Canton Ticino

Switzerland

Research Site

Chur

Kanton Graubünden

Switzerland

Research Site

Ilanz

Kanton Graubünden

Switzerland

Research Site

Samedan

Kanton Graubünden

Switzerland

Research Site

Kreuzlingen

Thurgau

Switzerland

Research Site

Ardon

Valais

Switzerland

Research Site

Evionnaz

Valais

Switzerland

Research Site

Savièse

Valais

Switzerland

Research Site

Sierre

Valais

Switzerland

Research Site

Sion

Valais

Switzerland

ID	Term
D012164	Retinal Diseases
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D005128	Eye Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided