Eye Diseases, Gestational Diabetes, Oxidative Stress, Retinal Disease
Conditions
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.
Interventions
OTHERtear test and eye measurement
tear test and eye measurement
Sponsors
Suzan Dogruya
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Levels of the Groups in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | 26 weeks of pregnant | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | 26 weeks pregnant women | 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 |
| Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | 26 weeks of pregnant | 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 |
| Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | 26 weeks of pregnant | Retinal nerve fiber temporal quadrant thickness in the pregnant group with blood sugar disorders and/or gestational DM, and control group |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
medical clinic
Pre-assignment details
women with impaired glucose status and normal glucose status
Participants by arm
| Arm | Count |
|---|---|
| Control Group Non diabetic women
tear test and eye measurement: tear test and eye measurement | 34 |
| Case Group Women with impairment glucose status
tear test and eye measurement: tear test and eye measurement | 26 |
| Total | 60 |
Baseline characteristics
| Characteristic | Case Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 28.30 years STANDARD_DEVIATION 4.81 | 27.05 years STANDARD_DEVIATION 4.86 | 25.94 years STANDARD_DEVIATION 4.5 |
| BMI | 27.76 kg/m² STANDARD_DEVIATION 5.93 | 27.85 kg/m² STANDARD_DEVIATION 5.605 | 27.94 kg/m² STANDARD_DEVIATION 5.28 |
| Mean RNFL, Temporal RNFL, CMT CMT Mean (standard Deviation) Unit of measure:µm | 252.08 µm STANDARD_DEVIATION 18.36 | 249.33 µm STANDARD_DEVIATION 18.85 | 246.59 µm STANDARD_DEVIATION 19.35 |
| Mean RNFL, Temporal RNFL, CMT Mean RNFL Mean (standard Deviation) Unit of measure:µm | 100.23 µm STANDARD_DEVIATION 10.87 | 101.07 µm STANDARD_DEVIATION 10.6 | 101.91 µm STANDARD_DEVIATION 10.34 |
| Mean RNFL, Temporal RNFL, CMT RNFL Temporal Mean (standard Deviation) Unit of measure:µm | 70.81 µm STANDARD_DEVIATION 16.43 | 75.67 µm STANDARD_DEVIATION 15.75 | 80.53 µm STANDARD_DEVIATION 15.08 |
| oxidative stress markers Disülfide Mean(Standart Deviation) Unit of measure: mmol/L | 8.75 mmol/L STANDARD_DEVIATION 1.84 | 9.75 mmol/L STANDARD_DEVIATION 4.17 | 10.76 mmol/L STANDARD_DEVIATION 6.5 |
| oxidative stress markers Native Thiol Mean(Standart Deviation) Unit of measure: mmol/L | 2.31 mmol/L STANDARD_DEVIATION 2.48 | 8.13 mmol/L STANDARD_DEVIATION 20.7 | 13.96 mmol/L STANDARD_DEVIATION 38.93 |
| oxidative stress markers Total Thiol Mean(Standart Deviation) Unit of measure: mmol/L | 19.76 mmol/L STANDARD_DEVIATION 2.93 | 27.25 mmol/L STANDARD_DEVIATION 25.68 | 34.75 mmol/L STANDARD_DEVIATION 48.44 |
| Race/Ethnicity, Customized | 26 Participants | 60 Participants | 34 Participants |
| Region of Enrollment Turkey | 26 Participants | 60 Participants | 34 Participants |
| Sex: Female, Male Female | 26 Participants | 60 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 26 |
| other Total, other adverse events | 0 / 34 | 0 / 26 |
| serious Total, serious adverse events | 0 / 34 | 0 / 26 |
Outcome results
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
Time frame: 26 weeks of pregnant
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Glucose Levels of the Groups in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | 50 gr (1hour) Mean(Standart Deviation) Unit of measure: mg/dl | 111.67 mg/dl | Standard Error 25.54 |
| Control Group | Glucose Levels of the Groups in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Fasting food sugar Mean(Standart Deviation) Unit of measure: mg/dl | 83.06 mg/dl | Standard Error 11.33 |
| Case Group | Glucose Levels of the Groups in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | 50 gr (1hour) Mean(Standart Deviation) Unit of measure: mg/dl | 154 mg/dl | Standard Error 24.29 |
| Case Group | Glucose Levels of the Groups in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Fasting food sugar Mean(Standart Deviation) Unit of measure: mg/dl | 88.15 mg/dl | Standard Error 14.33 |
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
Time frame: 26 weeks of pregnant
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Native Thiol Mean(Standart Deviation) Unit of measure: mmol/L | 13.96 mmol/L | Standard Deviation 38.93 |
| Control Group | Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Total Thiol Mean(Standart Deviation) Unit of measure: mmol/L | 34.75 mmol/L | Standard Deviation 48.44 |
| Control Group | Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Disülfide Mean(Standart Deviation) Unit of measure: mmol/L | 10.76 mmol/L | Standard Deviation 6.5 |
| Case Group | Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Disülfide Mean(Standart Deviation) Unit of measure: mmol/L | 8.75 mmol/L | Standard Deviation 1.84 |
| Case Group | Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Native Thiol Mean(Standart Deviation) Unit of measure: mmol/L | 2.31 mmol/L | Standard Deviation 2.48 |
| Case Group | Oxidative Stress Level in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Total Thiol Mean(Standart Deviation) Unit of measure: mmol/L | 19.76 mmol/L | Standard Deviation 2.93 |
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
Time frame: 26 weeks of pregnant
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Temporal RNFL Mean(Standart Deviation) Unit of measure:µm | 80.53 µm | Standard Deviation 15.08 |
| Control Group | Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Nasal RNFL Mean(Standart Deviation) Unit of measure:µm | 72.12 µm | Standard Deviation 10.65 |
| Control Group | Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Superior RNFL Mean(Standart Deviation) Unit of measure:µm | 123.82 µm | Standard Deviation 16.05 |
| Control Group | Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Inferior RNFL Mean(Standart Deviation) Unit of measure:µm | 132.59 µm | Standard Deviation 15.92 |
| Case Group | Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Inferior RNFL Mean(Standart Deviation) Unit of measure:µm | 128.23 µm | Standard Deviation 20.6 |
| Case Group | Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Temporal RNFL Mean(Standart Deviation) Unit of measure:µm | 70.81 µm | Standard Deviation 16.43 |
| Case Group | Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Superior RNFL Mean(Standart Deviation) Unit of measure:µm | 124.85 µm | Standard Deviation 15.78 |
| Case Group | Retinal Nerve Fiber Temporal Quadrant Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Nasal RNFL Mean(Standart Deviation) Unit of measure:µm | 72.27 µm | Standard Deviation 11.81 |
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
Time frame: 26 weeks pregnant women
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Mean RNFL Mean(Standart Deviation) Unit of measure:µm | 101.91 µm | Standard Error 10.34 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Superior RNFL Mean(Standart Deviation) Unit of measure:µm | 123.82 µm | Standard Error 16.05 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Inferior RNFL Mean(Standart Deviation) Unit of measure:µm | 132.59 µm | Standard Error 15.92 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Nasal RNFL Mean(Standart Deviation) Unit of measure:µm | 72.12 µm | Standard Error 10.65 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Temporal RNFL Mean(Standart Deviation) Unit of measure:µm | 80.53 µm | Standard Error 15.08 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula CMT Mean(Standart Deviation) Unit of measure:µm | 246.59 µm | Standard Error 19.35 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 3mm Superior Mean(Standart Deviation) Unit of measure:µm | 330.5 µm | Standard Error 14.79 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 3mm Inferior Mean(Standart Deviation) Unit of measure:µm | 326.91 µm | Standard Error 15.33 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 3mm Nasal Mean(Standart Deviation) Unit of measure:µm | 313.97 µm | Standard Error 11.98 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 3mm Temporal Mean(Standart Deviation) Unit of measure:µm | 330.88 µm | Standard Error 13.51 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 6mm Superior Mean(Standart Deviation) Unit of measure:µm | 299.21 µm | Standard Error 12.36 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 6mm Inferior Mean(Standart Deviation) Unit of measure:µm | 292.32 µm | Standard Error 22.82 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 6mm Nasal Mean(Standart Deviation) Unit of measure:µm | 280.44 µm | Standard Error 11.52 |
| Control Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 6mm Temporal Mean(Standart Deviation) Unit of measure:µm | 311.00 µm | Standard Error 10.88 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 6mm Superior Mean(Standart Deviation) Unit of measure:µm | 298.19 µm | Standard Error 12.72 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Mean RNFL Mean(Standart Deviation) Unit of measure:µm | 100.23 µm | Standard Error 10.87 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 3mm Inferior Mean(Standart Deviation) Unit of measure:µm | 330.92 µm | Standard Error 15.33 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Superior RNFL Mean(Standart Deviation) Unit of measure:µm | 124.85 µm | Standard Error 15.78 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 6mm Nasal Mean(Standart Deviation) Unit of measure:µm | 283.81 µm | Standard Error 10.26 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Inferior RNFL Mean(Standart Deviation) Unit of measure:µm | 128.23 µm | Standard Error 20.6 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 3mm Nasal Mean(Standart Deviation) Unit of measure:µm | 316.88 µm | Standard Error 17.15 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Nasal RNFL Mean(Standart Deviation) Unit of measure:µm | 72.27 µm | Standard Error 11.81 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 6mm Inferior Mean(Standart Deviation) Unit of measure:µm | 285.00 µm | Standard Error 10.1 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Temporal RNFL Mean(Standart Deviation) Unit of measure:µm | 70.81 µm | Standard Error 16.43 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 3mm Temporal Mean(Standart Deviation) Unit of measure:µm | 330.65 µm | Standard Error 12.48 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula CMT Mean(Standart Deviation) Unit of measure:µm | 252.08 µm | Standard Error 18.36 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 6mm Temporal Mean(Standart Deviation) Unit of measure:µm | 307.92 µm | Standard Error 12.84 |
| Case Group | Retinal Nerve Fiber Thickness and Macular Thickness in Pregnant Women With Impaired Blood Sugar and/or Gestational DM | Macula 3mm Superior Mean(Standart Deviation) Unit of measure:µm | 333.5 µm | Standard Error 14.94 |