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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Non diabetic women |
| |
| Case group | Women with impairment glucose status |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tear test and eye measurement | Other | tear test and eye measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 RNFL (mean, superior, inferior, nasal, temporal), mean central macular thickness, macula 3mm (mean, superior, inferior, nasal, temporal) and macula 6mm (mean, superior, inferior, nasal, temporal) were measured |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 60 pregnant women participated in the study. (30 gestational diabetes and/or impaired blood sugar and 30 healthy pregnant women).
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| Name | Affiliation | Role |
|---|---|---|
| Suzan Doğruya | Usak University Medical Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Usak University Medical Faculty | Uşak | 64000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20057426 | Background | 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. | |
| 12963518 | 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. |
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women with impaired glucose status and normal glucose status
medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Non diabetic women tear test and eye measurement: tear test and eye measurement |
| FG001 | Case Group | Women with impairment glucose status tear test and eye measurement: tear test and eye measurement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
control and case group (women with impaired glucose status) will undergo tear test and eye measurements
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Non diabetic women tear test and eye measurement: tear test and eye measurement |
| BG001 | Case Group | Women with impairment glucose status tear test and eye measurement: tear test and eye measurement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Women between the ages of 18 and 40 years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 34 control pregnant women and 26 pregnant women with impaired glucose tolerance were compared with fasting blood glucose and blood glucose at the 1st hour after 50 g sugar loading. | Posted | Mean | Standard Error | mg/dl | 26 weeks of pregnant |
|
up to 24 weeks
Serious Adverse Events is zero. All-Cause Mortality is zero. Other (Not Including Serious) Adverse Events is zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Non diabetic women tear test and eye measurement: tear test and eye measurement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzan Doğruya | Usak University Medical Faculty | 05322270732 | sdogruya@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 13, 2023 | Feb 26, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 13, 2023 | Feb 26, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| 26 weeks pregnant women |
| Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Native thiol values, total thiol and disulfide values in tears in the pregnant group with blood sugar disorders and/or gestational DM, and control group | 26 weeks of pregnant |
| Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Retinal nerve fiber temporal quadrant thickness in the pregnant group with blood sugar disorders and/or gestational DM, and control group | 26 weeks of pregnant |
| 20537747 | 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. |
| 21327985 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Turkish women were involved in this study | Count of Participants | Participants |
|
| Region of Enrollment | case control study, observational | Count of Participants | Participants |
|
| oxidative stress markers | BMI was obtained to patients, tear tests and eye measurements were done by primary investigator of the study | Mean | Standard Deviation | mmol/L |
|
| BMI | BMI was obtained to patients Mean(Standart Deviation) Unit of measure: kg/m² | Mean | Standard Deviation | kg/m² |
|
| Mean RNFL, Temporal RNFL, CMT | Eye measurements were done by primary investigator of the study | Mean | Standard Deviation | µm |
|
| Case Group |
Women with impairment glucose status tear test and eye measurement: tear test and eye measurement |
|
|
| Secondary | 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 RNFL (mean, superior, inferior, nasal, temporal), mean central macular thickness, macula 3mm (mean, superior, inferior, nasal, temporal) and macula 6mm (mean, superior, inferior, nasal, temporal) were measured | Retinal nerve fibre thickness and macular thickness were measured in 26 pregnant women with blood glucose disorders and/or gestational DM and 24 pregnant women in the control group. | Posted | Mean | Standard Error | µm | 26 weeks pregnant women |
|
|
|
| Secondary | Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Native thiol values, total thiol and disulfide values in tears in the pregnant group with blood sugar disorders and/or gestational DM, and control group | Natural thiol values, total thiol and disulphide values in tears of 26 pregnant women with blood glucose disorders and/or gestational DM and 34 control subjects | Posted | Mean | Standard Deviation | mmol/L | 26 weeks of pregnant |
|
|
|
| Secondary | Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Retinal nerve fiber temporal quadrant thickness in the pregnant group with blood sugar disorders and/or gestational DM, and control group | Retinal nerve fibre temporal quadrant thicknesses were measured in tears of 26 pregnant women with blood glucose disorders and/or gestational DM and 34 control subjects. | Posted | Mean | Standard Deviation | µm | 26 weeks of pregnant |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Case Group | Women with impairment glucose status tear test and eye measurement: tear test and eye measurement | 0 | 26 | 0 | 26 | 0 | 26 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Inferior RNFL Mean(Standart Deviation) Unit of measure:µm |
|
| Nasal RNFL Mean(Standart Deviation) Unit of measure:µm |
|
| Temporal RNFL Mean(Standart Deviation) Unit of measure:µm |
|
| Macula CMT Mean(Standart Deviation) Unit of measure:µm |
|
| Macula 3mm Superior Mean(Standart Deviation) Unit of measure:µm |
|
| Macula 3mm Inferior Mean(Standart Deviation) Unit of measure:µm |
|
| Macula 3mm Nasal Mean(Standart Deviation) Unit of measure:µm |
|
| Macula 3mm Temporal Mean(Standart Deviation) Unit of measure:µm |
|
| Macula 6mm Superior Mean(Standart Deviation) Unit of measure:µm |
|
| Macula 6mm Inferior Mean(Standart Deviation) Unit of measure:µm |
|
| Macula 6mm Nasal Mean(Standart Deviation) Unit of measure:µm |
|
| Macula 6mm Temporal Mean(Standart Deviation) Unit of measure:µm |
|
| Disülfide Mean(Standart Deviation) Unit of measure: mmol/L |
|
| Superior RNFL Mean(Standart Deviation) Unit of measure:µm |
|
| Inferior RNFL Mean(Standart Deviation) Unit of measure:µm |
|