Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01022177
First received: November 26, 2009
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Procedure: acupuncture
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • retinal perfusion by HRF/OBF/RVA [ Time Frame: post acupuncture (one day measurement) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: May 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Professor L.E. Pillunat, University of Dresden, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01022177     History of Changes
Other Study ID Numbers: AcuDiab1
Study First Received: November 26, 2009
Last Updated: December 1, 2011
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 22, 2014