NCT01022177

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 2, 2011

Status Verified

December 1, 2011

Enrollment Period

1 year

First QC Date

November 26, 2009

Last Update Submit

December 1, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • retinal perfusion by HRF/OBF/RVA

    post acupuncture (one day measurement)

Study Arms (2)

diabetics

ACTIVE COMPARATOR

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

Procedure: acupuncture

healthy

ACTIVE COMPARATOR

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

Procedure: acupuncture

Interventions

acupuncturePROCEDURE

acupuncture of the eye in traditional chinese schematics

Also known as: acupuncture therapy
diabeticshealthy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • persons over 18 years, men or women, diabetic diagnostics within the last year

You may not qualify if:

  • medical use of anticoagulative substances, use of dorzolamide, use of immunosuppressive medication
  • psychiatrics, epileptics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Carl Gustav Carus

Dresden, Saxony, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Janek - Haentzschel, Dr.

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2009

First Posted

December 1, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

May 1, 2012

Last Updated

December 2, 2011

Record last verified: 2011-12

Locations