EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS.

January 11, 2014 updated by: Gökhan Açmaz, Kayseri Education and Research Hospital
Gestational diabetes mellitus (GDM) is a risk factor for the development of type II diabetes and it is responsible for the morbidity of both mother and child. The aim of this study was to determine retinal findings of gestational diabetes mellitus (GDM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We have three groups; the first group consisted of pregnant volunteers with GDM. The second group consisted of healthy pregnant participants. The third group consisted of healthy, non-pregnant women at the reproductive age. Macular, choroid and retinal nerve fiber layer (RNFL) thicknesses were evaluated in patients with GDM and comparisons were made among GDM, healthy pregnant and healthy non-pregnant subjects for these parameters by using optic cohorence tomography.

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38210
        • Kayseri Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

Inclusion Criteria:

Singleton pregnancies Pregnancies between 26-28 weeks of gestation Gestational Diabetes

Exclusion Criteria:

  • ocular surgery ocular trauma glaucoma cystoid macular edema macular degeneration optic atrophy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers
This group consisted of age matched non-pregnant healthy volunteers
Other: Pregnant volunteers with GDM
Healthy pregnant volunteers
This group consisted of age matched healthy pregnant volunteers
Other: Pregnant volunteers with GDM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal evaluation
Time Frame: 6 weeks
The aim of this study was to determine retinal findings of gestational diabetes mellitus (GDM).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 11, 2014

First Submitted That Met QC Criteria

January 11, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 11, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GokhanAcmaz

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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