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Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus

T

Technische Universität Dresden

Status and phase

Unknown
Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Procedure: acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT01022177
AcuDiab1

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

diabetics
Active Comparator group
Description:
subjects with HbA1c \>7,0 and pathological glucose tolerance testing
Treatment:
Procedure: acupuncture
healthy
Active Comparator group
Description:
healthy subjects with HbA1c \<7,0 and negative glucose tolerance testing
Treatment:
Procedure: acupuncture

Trial contacts and locations

1

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Central trial contact

Janek - Haentzschel, Dr.; Kathleen - Wozniak, -

Data sourced from clinicaltrials.gov

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