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临床试验/NCT05958927
NCT05958927已完成不适用

Fundus Findings and Thiol-Disulfide Homeostais in Gestational Diabetes

Suzan Dogruya1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Glucose Levels of the Groups in Pregnant Women With Impaired Blood Sugar and/or Gestational DM

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Glucose Levels of the Groups in Pregnant Women With Impaired Blood Sugar and/or Gestational DM

时间窗: 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

次要结局

  • Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM(26 weeks pregnant women)
  • Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM(26 weeks of pregnant)
  • Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM(26 weeks of pregnant)

研究者

发起方
Suzan Dogruya
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Suzan Dogruya

Doctor

Uşak University

研究点 (1)

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