Fundus Findings and Thiol-Disulfide Homeostais

Oxidative Stress Clinical Trial

Official title:

Fundus Findings and Thiol-Disulfide Homeostais in Gestational Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958927
• Other study ID #: Gestational Diabetes
• Status: Recruiting
• Start date: April 13, 2023
• Est. completion date: November 2023

Study information

• Verified date: July 2023
• Source: Usak University
• Contact: Suzan Dogruya
• Phone: 532 227 07 32
• Email: sdogruya[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Eye Diseases
• Gestational Diabetes
• Oxidative Stress
• Retinal Disease
• Retinal Diseases

Locations

Country	Name	City	State
Turkey	Usak University Medical Faculty	Usak

Sponsors (1)

Lead Sponsor	Collaborator
Suzan Dogruya

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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