Fundus Findings and Thiol-Disulfide Homeostais

Fundus Findings and Thiol-Disulfide Homeostais in Gestational Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Eye Diseases; Oxidative Stress; Gestational Diabetes; Retinal Disease

Detailed Description

This is a prospective case-control study conducted in 30 pregnant patients diagnosed with gestational diabetes at 24-28 weeks of pregnancy and 30 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. (30 gestational diabetes and 30 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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Suzan Doğruya; Phone Number: 532 227 07 32; Email: sdogruya@hotmail.com

Study Locations

• Turkey
  • Uşak, Turkey, 64000
    • Recruiting
    • Usak University Medical Faculty
    • Contact: Suzan Doğruya; Phone Number: 05322270732; Email: sdogruya@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

A total of 60 pregnant women participated in the study. (30 gestational diabetes and/or impaired blood sugar and 30 healthy pregnant women).

Description

Example:

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thiol-disulfide level in tears in pregnant women with impaired blood sugar and/or gestational DM	Thiol-disulfide level (µmol/L) is measured by ELISA method in the tears of pregnant women with impaired blood sugar and/or gestational DM.	24 weeks -28 weeks of pregnant
Retinal nerve fiber thickness and macular thickness in pregnant women with impaired blood sugar and/or gestational DM	Retinal nerve fiber thickness and macular (µm) are measured by OCT in pregnant women with impaired blood sugar and/or gestational DM	24 weeks -28 weeks of pregnant

Collaborators and Investigators

• Sponsor: Suzan Dogruya
• Investigators: Principal Investigator: Suzan Doğruya, Usak University Medical Faculty

Publications and helpful links

General Publications

• Rask-Madsen C, King GL. Kidney complications: factors that protect the diabetic vasculature. Nat Med. 2010 Jan;16(1):40-1. doi: 10.1038/nm0110-40. No abstract available.
• Barbour LA. New concepts in insulin resistance of pregnancy and gestational diabetes: long-term implications for mother and offspring. J Obstet Gynaecol. 2003 Sep;23(5):545-9. doi: 10.1080/0144361031000156500. No abstract available.
• Karacay O, Sepici-Dincel A, Karcaaltincaba D, Sahin D, Yalvac S, Akyol M, Kandemir O, Altan N. A quantitative evaluation of total antioxidant status and oxidative stress markers in preeclampsia and gestational diabetic patients in 24-36 weeks of gestation. Diabetes Res Clin Pract. 2010 Sep;89(3):231-8. doi: 10.1016/j.diabres.2010.04.015.
• Lopez-Tinoco C, Roca M, Garcia-Valero A, Murri M, Tinahones FJ, Segundo C, Bartha JL, Aguilar-Diosdado M. Oxidative stress and antioxidant status in patients with late-onset gestational diabetes mellitus. Acta Diabetol. 2013 Apr;50(2):201-8. doi: 10.1007/s00592-011-0264-2. Epub 2011 Feb 17.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Eye Diseases; Diabetes, Gestational
• Other Study ID Numbers: Gestational Diabetes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No