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

NCT ID: NCT02035995

Last Updated: 2014-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Retinal Evaluation in Patients With GDM.

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers

This group consisted of age matched non-pregnant healthy volunteers

Pregnant volunteers with GDM

Intervention Type OTHER

Healthy pregnant volunteers

This group consisted of age matched healthy pregnant volunteers

Pregnant volunteers with GDM

Intervention Type OTHER

Interventions

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Pregnant volunteers with GDM

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kayseri Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gökhan Açmaz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kayseri Education and Research Hospital

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GokhanAcmaz

Identifier Type: -

Identifier Source: org_study_id

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