Fundus Findings and Thiol-Disulfide Homeostais

NCT ID: NCT05958927

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2024-02-17

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.

Conditions

Gestational Diabetes; Eye Diseases; Retinal Disease; Oxidative Stress

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group

Non diabetic women

tear test and eye measurement

Intervention Type: OTHER

tear test and eye measurement

Case group

Women with impairment glucose status

tear test and eye measurement

Intervention Type: OTHER

tear test and eye measurement

Interventions

tear test and eye measurement

tear test and eye measurement

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Suzan Dogruya

OTHER

Sponsor Role: lead

Responsible Party

Suzan Dogruya

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Suzan Doğruya

Role: PRINCIPAL_INVESTIGATOR

Usak University Medical Faculty

Locations

Usak University Medical Faculty

Uşak, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 20057426 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12963518 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20537747 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21327985 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Gestational Diabetes

Identifier Type: -

Identifier Source: org_study_id