Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

December 1, 2011 updated by: Technische Universität Dresden
The purpose of this study is to determine the influence of specific eye acupuncture to the ocular microcirculation in diabetic and healthy subjects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxonia
      • Dresden, Saxonia, Germany, 01307
        • Recruiting
        • University Carl Gustav Carus
        • Sub-Investigator:
          • Kathleen - Wozniak, -

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: diabetics
subjects with HbA1c >7,0 and pathological glucose tolerance testing
Procedure: acupuncture
acupuncture of the eye in traditional chinese schematics
Other Names:
  • acupuncture therapy
Active Comparator: healthy
healthy subjects with HbA1c <7,0 and negative glucose tolerance testing
Procedure: acupuncture
acupuncture of the eye in traditional chinese schematics
Other Names:
  • acupuncture therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
retinal perfusion by HRF/OBF/RVA
Time Frame: post acupuncture (one day measurement)
post acupuncture (one day measurement)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Study Director: Janek - Haentzschel, Dr.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

November 26, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

December 2, 2011

Last Update Submitted That Met QC Criteria

December 1, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AcuDiab1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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