Trial Outcomes & Findings for Fundus Findings and Thiol-Disulfide Homeostais (NCT NCT05958927)
NCT ID: NCT05958927
Last Updated: 2025-03-10
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
60 participants
Primary outcome timeframe
26 weeks of pregnant
Results posted on
2025-03-10
Participant Flow
medical clinic
women with impaired glucose status and normal glucose status
Participant milestones
| Measure |
Control Group
Non diabetic women
tear test and eye measurement: tear test and eye measurement
|
Case Group
Women with impairment glucose status
tear test and eye measurement: tear test and eye measurement
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
26
|
|
Overall Study
COMPLETED
|
34
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fundus Findings and Thiol-Disulfide Homeostais
Baseline characteristics by cohort
| Measure |
Control Group
n=34 Participants
Non diabetic women
tear test and eye measurement: tear test and eye measurement
|
Case Group
n=26 Participants
Women with impairment glucose status
tear test and eye measurement: tear test and eye measurement
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.94 years
STANDARD_DEVIATION 4.50 • n=5 Participants
|
28.30 years
STANDARD_DEVIATION 4.81 • n=7 Participants
|
27.05 years
STANDARD_DEVIATION 4.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
oxidative stress markers
Native Thiol Mean(Standart Deviation) Unit of measure: mmol/L
|
13.96 mmol/L
STANDARD_DEVIATION 38.93 • n=5 Participants
|
2.31 mmol/L
STANDARD_DEVIATION 2.48 • n=7 Participants
|
8.13 mmol/L
STANDARD_DEVIATION 20.70 • n=5 Participants
|
|
oxidative stress markers
Total Thiol Mean(Standart Deviation) Unit of measure: mmol/L
|
34.75 mmol/L
STANDARD_DEVIATION 48.44 • n=5 Participants
|
19.76 mmol/L
STANDARD_DEVIATION 2.93 • n=7 Participants
|
27.25 mmol/L
STANDARD_DEVIATION 25.68 • n=5 Participants
|
|
oxidative stress markers
Disülfide Mean(Standart Deviation) Unit of measure: mmol/L
|
10.76 mmol/L
STANDARD_DEVIATION 6.5 • n=5 Participants
|
8.75 mmol/L
STANDARD_DEVIATION 1.84 • n=7 Participants
|
9.75 mmol/L
STANDARD_DEVIATION 4.17 • n=5 Participants
|
|
BMI
|
27.94 kg/m²
STANDARD_DEVIATION 5.28 • n=5 Participants
|
27.76 kg/m²
STANDARD_DEVIATION 5.93 • n=7 Participants
|
27.85 kg/m²
STANDARD_DEVIATION 5.605 • n=5 Participants
|
|
Mean RNFL, Temporal RNFL, CMT
Mean RNFL Mean (standard Deviation) Unit of measure:µm
|
101.91 µm
STANDARD_DEVIATION 10.34 • n=5 Participants
|
100.23 µm
STANDARD_DEVIATION 10.87 • n=7 Participants
|
101.07 µm
STANDARD_DEVIATION 10.60 • n=5 Participants
|
|
Mean RNFL, Temporal RNFL, CMT
RNFL Temporal Mean (standard Deviation) Unit of measure:µm
|
80.53 µm
STANDARD_DEVIATION 15.08 • n=5 Participants
|
70.81 µm
STANDARD_DEVIATION 16.43 • n=7 Participants
|
75.67 µm
STANDARD_DEVIATION 15.75 • n=5 Participants
|
|
Mean RNFL, Temporal RNFL, CMT
CMT Mean (standard Deviation) Unit of measure:µm
|
246.59 µm
STANDARD_DEVIATION 19.35 • n=5 Participants
|
252.08 µm
STANDARD_DEVIATION 18.36 • n=7 Participants
|
249.33 µm
STANDARD_DEVIATION 18.85 • n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeks of pregnantPopulation: 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.
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
Outcome measures
| Measure |
Control Group
n=34 Participants
Non diabetic women
tear test and eye measurement: tear test and eye measurement
|
Case Group
n=26 Participants
Women with impairment glucose status
tear test and eye measurement: tear test and eye measurement
|
|---|---|---|
|
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
|
154 mg/dl
Standard Error 24.29
|
|
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
|
88.15 mg/dl
Standard Error 14.33
|
SECONDARY outcome
Timeframe: 26 weeks pregnant womenPopulation: 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.
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
Outcome measures
| Measure |
Control Group
n=34 Participants
Non diabetic women
tear test and eye measurement: tear test and eye measurement
|
Case Group
n=26 Participants
Women with impairment glucose status
tear test and eye measurement: tear test and eye measurement
|
|---|---|---|
|
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
|
100.23 µm
Standard Error 10.87
|
|
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
|
124.85 µm
Standard Error 15.78
|
|
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
|
128.23 µm
Standard Error 20.6
|
|
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
|
72.27 µm
Standard Error 11.81
|
|
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
|
70.81 µm
Standard Error 16.43
|
|
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
|
252.08 µm
Standard Error 18.36
|
|
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
|
333.5 µm
Standard Error 14.94
|
|
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
|
330.92 µm
Standard Error 15.33
|
|
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
|
316.88 µm
Standard Error 17.15
|
|
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
|
330.65 µm
Standard Error 12.48
|
|
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
|
298.19 µm
Standard Error 12.72
|
|
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
|
285.00 µm
Standard Error 10.10
|
|
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
|
283.81 µm
Standard Error 10.26
|
|
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
|
307.92 µm
Standard Error 12.84
|
SECONDARY outcome
Timeframe: 26 weeks of pregnantPopulation: 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
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
Outcome measures
| Measure |
Control Group
n=34 Participants
Non diabetic women
tear test and eye measurement: tear test and eye measurement
|
Case Group
n=26 Participants
Women with impairment glucose status
tear test and eye measurement: tear test and eye measurement
|
|---|---|---|
|
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
|
8.75 mmol/L
Standard Deviation 1.84
|
|
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
|
2.31 mmol/L
Standard Deviation 2.48
|
|
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
|
19.76 mmol/L
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: 26 weeks of pregnantPopulation: 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.
Retinal nerve fiber temporal quadrant thickness in the pregnant group with blood sugar disorders and/or gestational DM, and control group
Outcome measures
| Measure |
Control Group
n=34 Participants
Non diabetic women
tear test and eye measurement: tear test and eye measurement
|
Case Group
n=26 Participants
Women with impairment glucose status
tear test and eye measurement: tear test and eye measurement
|
|---|---|---|
|
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
|
70.81 µm
Standard Deviation 16.43
|
|
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
|
72.27 µm
Standard Deviation 11.81
|
|
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
|
124.85 µm
Standard Deviation 15.78
|
|
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
|
128.23 µm
Standard Deviation 20.6
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Case Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place