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Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Carl Gustav CarusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

diabetics

healthy

Arm Description

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

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

Outcomes

Primary Outcome Measures

retinal perfusion by HRF/OBF/RVA

Secondary Outcome Measures

Full Information

First Posted
November 26, 2009
Last Updated
December 1, 2011
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT01022177
Brief Title
Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus
Official Title
Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
diabetics
Arm Type
Active Comparator
Arm Description
subjects with HbA1c >7,0 and pathological glucose tolerance testing
Arm Title
healthy
Arm Type
Active Comparator
Arm Description
healthy subjects with HbA1c <7,0 and negative glucose tolerance testing
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Other Intervention Name(s)
acupuncture therapy
Intervention Description
acupuncture of the eye in traditional chinese schematics
Primary Outcome Measure Information:
Title
retinal perfusion by HRF/OBF/RVA
Time Frame
post acupuncture (one day measurement)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janek - Haentzschel, Dr.
Phone
0351-4583381
Email
Janek.Haentzschel@uniklinikum-dresden.de
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen - Wozniak, -
Phone
0351-4583381
Email
Kathleen.Wozniak@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janek - Haentzschel, Dr.
Official's Role
Study Director
Facility Information:
Facility Name
University Carl Gustav Carus
City
Dresden
State/Province
Saxonia
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen - Wozniak, -

12. IPD Sharing Statement

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Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

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