Fundus Findings and Thiol-Disulfide Homeostais

Completed

Conditions: Gestational Diabetes
Eye Diseases
Retinal Disease
Oxidative Stress

Registration Number: NCT05958927

Lead Sponsor: Suzan Dogruya

Brief Summary: Gestational diabetes mellitus is associated with abnormal blood sugar levels throughout pregnancy in women without prior diabetes. Many studies have been conducted on the relationship between diabetes and oxidative stress. In this study, it was aimed to investigate the presence of fundus findings in patients with gestational diabetes and/or impaired blood sugar based on the results of previous studies and to simultaneously investigate the thiol-disulfide homeostasis in the tears of the patients.There was no previous study in the literature on thiol disulfide homeostasis in tears in gestational diabetic patients.

Detailed Description: This is a prospective case-control study conducted in 26 pregnant patients diagnosed with gestational diabetes at 24-28 weeks of pregnancy and 34 healthy pregnant women without gestational diabetes in the Uşak Training and Research Hospital Gynecology and Ophthalmology clinic. Glucose tolerance test; If the plasma glucose was 140 mg/dl or higher in the 1st hour after an oral 50 g glucose load, 100 g glucose was added after 8 hours of fasting. The result of 100 gr OGTT was evaluated according to Carpenter and Coustan criteria. Gestational diabetes was diagnosed if two or more of the four glucose levels were abnormal according to the Carpenter and Coustan criteria. Gestational diabetes was diagnosed if the plasma glucose level was 200 mg and above in pregnant women who were loaded with 50 g glucose.

A total of 60 pregnant women participated in the study. (26 gestational diabetes and 34 healthy pregnant women). Investigators excluded patients with type 1diabetes mellitus and type 2 diabetes mellitus, patient that history of ocular surface disease, topical/systemic medical therapy,with ocular inflamatuar disease such as üveitis. The patients who is healthy pregnant and gestasional diabetes mellitus pregnant were recruit to this study. Controls group included only healthy pregnant.

Tears analysis is less invasive, safe and accaptable method for research

All patients underwent a comprehensive ophthalmologic examination that included best-corrected visual acuity, slit-lamp examination, dilated fundus examination and applanation tonometry. Based on the International Clinical DR Disease Severity Scale (ICDRS).

Tears analysis is less invasive, safe and accaptable method for research. Tear samples, Schirmer paper strips were placed in the lower conjunctival fornix of the right eye for a maximum of 5 minutes. Care was taken not to use tear stimulation, topical anesthetic or other eye drops. Attention was paid to factors such as lighting and room temperature. The ocular surface was not damaged. Tear samples were collected by a single individual (SD). A 15-20 mm test result was considered as enough for biochemical analysis. Schirmer strips were diluted with 500 μl previously cooled PBS (phosphate-buffered saline), and stored in Eppendorf tubes until analysis (-80 °C).

At the end of the study, fundus findings and tear oxidative stress values of both groups will be compared.ELISA method will be used for determination of tear oxidative stress findings.

The study followed the tenets of the declaration of Helsinki and was approved by the Uşak üniversitesi Ethics Committee (13.04.2023 / 93-93-04). Written and informed con-sent of participants was obtained for each patient prior to the study.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 60

Inclusion Criteria

Healthy pregnant at 24-28 weeks of pregnancy
Pregnant patients diagnosed with gestational diabetes and/or impaired blood sugar at 24-28 weeks of pregnancy

Exclusion Criteria

Type 1diabetes mellitus,
Type 2 diabetes mellitus,
Patient that history of ocular surface disease,
Topical/systemic medical therapy with ocular inflamatuar disease such as üveitis.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose Levels of the Groups in Pregnant Women With Impaired Blood Sugar and/or Gestational DM	26 weeks of pregnant	All patients underwent a 50-g GTT at any time of the day. Women with ≥ 140 mg/dL on the 50-g GTT in the first hour but with a normal 100-g oral GTT level were included in the hyperglycemia group. Women with a 50-g GTT level \< 140 mg/dL were categorized as normal and included in the control group

Secondary Outcome Measures

Name	Time	Method
Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM	26 weeks pregnant women	Retinal nerve fiber thickness and macular (µm) are measured by OCT in pregnant women with impaired blood sugar and/or gestational DM RNFL (mean, superior, inferior, nasal, temporal), mean central macular thickness, macula 3mm (mean, superior, inferior, nasal, temporal) and macula 6mm (mean, superior, inferior, nasal, temporal) were measured
Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM	26 weeks of pregnant	Native thiol values, total thiol and disulfide values in tears in the pregnant group with blood sugar disorders and/or gestational DM, and control group
Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM	26 weeks of pregnant	Retinal nerve fiber temporal quadrant thickness in the pregnant group with blood sugar disorders and/or gestational DM, and control group