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

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ClinicalTrials.gov Identifier: NCT02035995
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gökhan Açmaz, Kayseri Education and Research Hospital

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
Retinal Evaluation in Patients With GDM. Other: Pregnant volunteers with GDM

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 76 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS.
Study Start Date : January 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Retinal evaluation [ Time Frame: 6 weeks ]
    The aim of this study was to determine retinal findings of gestational diabetes mellitus (GDM).


Biospecimen Retention:   None Retained
no biospecimens are to be retained

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035995


Locations
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Turkey
Kayseri Education and Research Hospital
Kayseri, Turkey, 38210
Sponsors and Collaborators
Kayseri Education and Research Hospital
More Information
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Additional Information:

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Responsible Party: Gökhan Açmaz, MD, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02035995    
Other Study ID Numbers: GokhanAcmaz
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Gökhan Açmaz, Kayseri Education and Research Hospital:
gestational diabetes mellitus; optical coherence tomography; pregnancy; retinal nerve fiber layer.
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications