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Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

NCT ID: NCT01022177

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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diabetics

subjects with HbA1c \>7,0 and pathological glucose tolerance testing

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type PROCEDURE

acupuncture of the eye in traditional chinese schematics

healthy

healthy subjects with HbA1c \<7,0 and negative glucose tolerance testing

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type PROCEDURE

acupuncture of the eye in traditional chinese schematics

Interventions

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acupuncture

acupuncture of the eye in traditional chinese schematics

Intervention Type PROCEDURE

Other Intervention Names

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acupuncture therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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University of Dresden, Department of Ophthalmology

Principal Investigators

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Janek - Haentzschel, Dr.

Role: STUDY_DIRECTOR

Locations

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University Carl Gustav Carus

Dresden, Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Janek - Haentzschel, Dr.

Role: CONTACT

Phone: 0351-4583381

Email: [email protected]

Kathleen - Wozniak, -

Role: CONTACT

Phone: 0351-4583381

Email: [email protected]

Other Identifiers

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AcuDiab1

Identifier Type: -

Identifier Source: org_study_id