Trial Outcomes & Findings for Estrogen and Diabetes (NCT NCT03436992)
NCT ID: NCT03436992
Last Updated: 2025-02-17
Results Overview
Flow-Mediated Dilation (FMD) controlled for shear
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
143 participants
Primary outcome timeframe
~ 2 weeks. Acquired at Menses and Late Follicular phase.
Results posted on
2025-02-17
Participant Flow
These results were based on a subset (n=57) of the total enrollment of 143.
Participant milestones
| Measure |
T1M Women
women with type 1 diabetes
|
Controls
apparently healthy women
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
25
|
|
Overall Study
COMPLETED
|
32
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Estrogen and Diabetes
Baseline characteristics by cohort
| Measure |
T1M Women
n=32 Participants
women with type 1 diabetes
|
Controls
n=25 Participants
apparently healthy women
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
STANDARD_DEVIATION 6 • n=5 Participants
|
24 years
STANDARD_DEVIATION 6 • n=7 Participants
|
25 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
163.5 cm
STANDARD_DEVIATION 7.0 • n=5 Participants
|
165.4 cm
STANDARD_DEVIATION 5.8 • n=7 Participants
|
164.3 cm
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Weight
|
72.8 kg
STANDARD_DEVIATION 17.6 • n=5 Participants
|
68.4 kg
STANDARD_DEVIATION 15.8 • n=7 Participants
|
70.9 kg
STANDARD_DEVIATION 16.8 • n=5 Participants
|
|
BMI
|
27.2 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
24.5 kg/m^2
STANDARD_DEVIATION 4.7 • n=7 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
MAP
|
87 mm Hg
STANDARD_DEVIATION 8 • n=5 Participants
|
83 mm Hg
STANDARD_DEVIATION 7 • n=7 Participants
|
85 mm Hg
STANDARD_DEVIATION 8 • n=5 Participants
|
|
CRP
|
5.4 mg/L
STANDARD_DEVIATION 8.3 • n=5 Participants
|
1.2 mg/L
STANDARD_DEVIATION 1.3 • n=7 Participants
|
3.6 mg/L
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
TC
|
178 mg/dL
STANDARD_DEVIATION 41 • n=5 Participants
|
163 mg/dL
STANDARD_DEVIATION 35 • n=7 Participants
|
171 mg/dL
STANDARD_DEVIATION 39 • n=5 Participants
|
|
HDL
|
58 mg/dL
STANDARD_DEVIATION 17 • n=5 Participants
|
53 mg/dL
STANDARD_DEVIATION 13 • n=7 Participants
|
56 mg/dL
STANDARD_DEVIATION 15 • n=5 Participants
|
|
LDL
|
98 mg/dL
STANDARD_DEVIATION 42 • n=5 Participants
|
88 mg/dL
STANDARD_DEVIATION 39 • n=7 Participants
|
94 mg/dL
STANDARD_DEVIATION 41 • n=5 Participants
|
|
TRIG
|
76 mg/dL
STANDARD_DEVIATION 45 • n=5 Participants
|
63 mg/dL
STANDARD_DEVIATION 28 • n=7 Participants
|
70 mg/dL
STANDARD_DEVIATION 39 • n=5 Participants
|
|
TC/HDL ratio
|
3.2 ratio
STANDARD_DEVIATION 1.1 • n=5 Participants
|
3.2 ratio
STANDARD_DEVIATION 0.8 • n=7 Participants
|
3.2 ratio
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
HbA1c
|
8.6 percent
STANDARD_DEVIATION 1.7 • n=5 Participants
|
5.2 percent
STANDARD_DEVIATION 0.3 • n=7 Participants
|
7.1 percent
STANDARD_DEVIATION 2.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: ~ 2 weeks. Acquired at Menses and Late Follicular phase.Flow-Mediated Dilation (FMD) controlled for shear
Outcome measures
| Measure |
T1M Women
n=32 Participants
women with type 1 diabetes
|
Controls
n=25 Participants
apparently healthy women
|
|---|---|---|
|
FMD/Shear
Menses
|
0.182 %/s^-1
Standard Deviation 0.068
|
0.206 %/s^-1
Standard Deviation 0.100
|
|
FMD/Shear
Late Follicular
|
0.155 %/s^-1
Standard Deviation 0.059
|
0.219 %/s^-1
Standard Deviation 0.110
|
Adverse Events
T1M Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
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