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NCT01022177 Clinical Trial

Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01022177
Other study ID # AcuDiab1
Secondary ID
Status Recruiting
Phase Phase 2
First received November 26, 2009
Last updated December 1, 2011
Start date October 2009
Est. completion date May 2012

Study information
Verified date December 2011
Source Technische Universität Dresden
Contact Janek - Haentzschel, Dr.
Phone 0351-4583381
Email Janek.Haentzschel@uniklinikum-dresden.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the influence of specific eye acupuncture to the ocular microcirculation in diabetic and healthy subjects.

Description:

Diabetes is combined with severe vascular damage at the different stages of the disease, causing reduction in retinal perfusion. Acupuncture is supposed to regulate the perfusion. We propose a study to evaluate the effect of acupuncture to the vascular auto regulation in patient with Diabetes, compared to healthy people without vascular or retinal diseases. The perfusion of the retinal vessel will be examined by Retinal vessel analyzer (RVA), Heidelberg retinal Flowmeter (HRF) and the Ocular blood Flowmeter (OBF) before, during and after standardized specific acupuncture at healthy volunteers and patients with diabetes.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date May 2012
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- persons over 18 years, men or women, diabetic diagnostics within the last year

Exclusion Criteria:

- medical use of anticoagulative substances, use of dorzolamide, use of immunosuppressive medication

- psychiatrics, epileptics

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• acupuncture
acupuncture of the eye in traditional chinese schematics

Locations
Country Name City State
Germany University Carl Gustav Carus Dresden Saxonia

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary retinal perfusion by HRF/OBF/RVA post acupuncture (one day measurement) No
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