Fundus Findings and Thiol-Disulfide Homeostais

NCT05958927 | Completed Results

• 1 other identifier: Gestational Diabetes
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Eye Diseases; Retinal Disease; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

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

  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

  26 weeks of pregnant

Secondary Outcomes (3)

• 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

Study Arms (2)

Control group

Non diabetic women

Other: tear test and eye measurement

Case group

Women with impairment glucose status

Other: tear test and eye measurement

Interventions

tear test and eye measurement OTHER

tear test and eye measurement

Case group; Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzan Dogruya: lead

Study Sites (1)

Usak University Medical Faculty

Uşak, 64000, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 20057426 BACKGROUND

• 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.

  PMID: 12963518 BACKGROUND

• 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.

  PMID: 20537747 BACKGROUND

• 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.

  PMID: 21327985 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Eye Diseases; Retinal Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Suzan Doğruya
• Organization: Usak University Medical Faculty

sdogruya@hotmail.com

05322270732

Study Officials

• Suzan Doğruya

  Usak University Medical Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 25, 2023
• Study Start: April 13, 2023
• Primary Completion: February 17, 2024
• Study Completion: February 17, 2024
• Last Updated: March 10, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)