NCT01771835

Brief Summary

Measurement of the circulation in patients with diabetes mellitus and establish a link between retinal venous pressure (RVP) and endothelin (ET-1)levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

1.1 years

First QC Date

October 24, 2012

Last Update Submit

January 16, 2013

Conditions

Diabetes Mellitus

Keywords

diabetes mellitusretinal venous pressureendothelin-1

Outcome Measures

Primary Outcomes (1)

  • Quantification of retinal venous pressure (RVP)

    30 minutes

Secondary Outcomes (1)

  • Quantification of ET-1 in correlation with RVP

    30 minutes

Study Arms (1)

Diabetes patients

Patients with diabetes mellitus type I + II, without diabetic retinopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diabets mellitus type I or II, without diabetic retinopathy

You may qualify if:

  • diabetes mellitus type I or II
  • no diabetic retinopathy

You may not qualify if:

  • known diabetic retinopathy
  • acute or chronic inflammation of the eyes
  • narrow angle glaucoma
  • minority

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel, Dept. of Ophthalmology

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Cybulska-Heinrich AK, Baertschi M, Loesche CC, Schoetzau A, Konieczka K, Josifova T, Flammer J. Patients with diabetic retinopathy have high retinal venous pressure. EPMA J. 2015 Feb 24;6(1):5. doi: 10.1186/s13167-015-0027-1. eCollection 2015.

    PMID: 25793018DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Josef Flammer, MD

    University of Basel, Dept. of Ophthalmology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2012

First Posted

January 18, 2013

Study Start

August 1, 2011

Primary Completion

September 1, 2012

Study Completion

November 1, 2012

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

CH(1)