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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

Tracking Information
First Submitted Date January 11, 2014
First Posted Date January 14, 2014
Last Update Posted Date January 14, 2014
Study Start Date January 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2014)
Retinal evaluation [ Time Frame: 6 weeks ]
The aim of this study was to determine retinal findings of gestational diabetes mellitus (GDM).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS.
Official Title EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS.
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).
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 [Patient Registry]
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration 6 Weeks
Biospecimen Retention:   None Retained
Description:
no biospecimens are to be retained
Sampling Method Non-Probability Sample
Study Population Community sample
Condition Retinal Evaluation in Patients With GDM.
Intervention Other: Pregnant volunteers with GDM
Study Groups/Cohorts
  • Healthy volunteers
    This group consisted of age matched non-pregnant healthy volunteers
    Intervention: Other: Pregnant volunteers with GDM
  • Healthy pregnant volunteers
    This group consisted of age matched healthy pregnant volunteers
    Intervention: Other: Pregnant volunteers with GDM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 11, 2014)
76
Original Actual Enrollment Same as current
Actual Study Completion Date July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT02035995
Other Study ID Numbers GokhanAcmaz
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gökhan Açmaz, Kayseri Education and Research Hospital
Study Sponsor Kayseri Education and Research Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Kayseri Education and Research Hospital
Verification Date January 2014