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Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01022177
Recruitment Status : Unknown
Verified December 2011 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : December 1, 2009
Last Update Posted : December 2, 2011
Sponsor:
Information provided by:
Technische Universität Dresden

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Procedure: acupuncture Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus
Study Start Date : October 2009
Primary Completion Date : October 2010
Estimated Study Completion Date : May 2012

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U.S. FDA Resources

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 Name: 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 Name: acupuncture therapy



Primary Outcome Measures :
  1. retinal perfusion by HRF/OBF/RVA [ Time Frame: post acupuncture (one day measurement) ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01022177


Contacts
Contact: Janek - Haentzschel, Dr. 0351-4583381 Janek.Haentzschel@uniklinikum-dresden.de
Contact: Kathleen - Wozniak, - 0351-4583381 Kathleen.Wozniak@uniklinikum-dresden.de

Locations
Germany
University Carl Gustav Carus Recruiting
Dresden, Saxonia, Germany, 01307
Sub-Investigator: Kathleen - Wozniak, -         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Study Director: Janek - Haentzschel, Dr.

Responsible Party: Professor L.E. Pillunat, University of Dresden, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01022177     History of Changes
Other Study ID Numbers: AcuDiab1
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases