Trial Outcomes & Findings for The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women (NCT NCT03681691)
NCT ID: NCT03681691
Last Updated: 2022-09-27
Results Overview
Brain metabolism will be measured using PET tracers to examine brain glucose uptake (FDG PET). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of FDG will be quantified.
COMPLETED
PHASE1
12 participants
Baseline
2022-09-27
Participant Flow
Participant milestones
| Measure |
Post Menopausal Women With Diabetes
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women Without Diabetes
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Post Menopausal Women With Diabetes
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women Without Diabetes
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Overall Study
COVID
|
1
|
0
|
|
Overall Study
prolonged bleeding
|
1
|
0
|
|
Overall Study
veins would not stay open during the PET scan.
|
0
|
1
|
Baseline Characteristics
The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Post Menopausal Women With Diabetes
n=8 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women Without Diabetes
n=4 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
70.0 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 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
|
1 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 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
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Non-Diabetes: n=2, technical error resulted in issues reconstructing PET images for one participant. Results only reported for subjects who completed study.
Brain metabolism will be measured using PET tracers to examine brain glucose uptake (FDG PET). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of FDG will be quantified.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=2 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)--Whole Brain
|
12.28 micromoles/min/100g tissue
Standard Deviation 11.39
|
11.75 micromoles/min/100g tissue
Standard Deviation 12.42
|
PRIMARY outcome
Timeframe: Week 8Population: Non-Diabetes: n=2, technical error resulted in issues reconstructing PET images for one participant. Results only reported for subjects who completed study.
Brain metabolism will be measured using PET tracers to examine brain glucose uptake (FDG PET). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of FDG will be quantified.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=2 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
FDG PET--Whole Brain
|
8.74 micromoles/min/100g tissue
Standard Deviation 2.59
|
6.87 micromoles/min/100g tissue
Standard Deviation 0.88
|
PRIMARY outcome
Timeframe: BaselinePopulation: Non-Diabetes: n=2, technical error resulted in issues reconstructing PET images for one participant. Results only reported for subjects who completed study.
Brain metabolism will be measured using PET tracers to examine brain ketone body (acetoacetate) uptake (AcAc). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of AcAc tracers will be quantified.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=2 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Acetoacetate Uptake (AcAc) PET--Whole Brain
|
0.031 micromoles/min/100g tissue
Standard Deviation 0.009
|
0.024 micromoles/min/100g tissue
Standard Deviation 0.005
|
PRIMARY outcome
Timeframe: Week 8Population: Non-Diabetes: n=2, technical error resulted in issues reconstructing PET images for one participant. Results only reported for subjects who completed study.
Brain metabolism will be measured using PET tracers to examine brain ketone body (acetoacetate) uptake (AcAc). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of AcAc tracers will be quantified.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=2 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
AcAc PET--Whole Brain
|
0.027 micromoles/min/100g tissue
Standard Deviation 0.003
|
0.028 micromoles/min/100g tissue
Standard Deviation 0.015
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: This outcome measure is actually many outcome measures. It was broken down into the other four primary outcome measures listed, so no no results will be listed here. Also, rather than "change in", results will be reported as mean/standard deviation in the other outcomes.
Brain metabolism will be measured using PET tracers to examine brain glucose uptake (FDG PET) and ketone body (acetoacetate) uptake (AcAc). PET imaging data are co-registered to T1 structural MRI data to conduct region-of-interest based analyses. Absolute global and regional uptake of FDG and AcAc tracers will be quantified, as well as uptake of AcAc relative to FDG to find potential regions of compensatory ketone use
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
A composite memory score was created by averaging z-scores for CVLT delayed recall, BVRT delayed recall, and prospective memory. A composite executive function score was created by averaging digit span forwards total correct, digit span backwards total correct, and both verbal fluency scores. Summed z-score ranging from -2 to 2 where higher score indicates better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Short-Term Memory Composite Score
Baseline
|
1.04 z-score
Standard Deviation 0.31
|
-0.52 z-score
Standard Deviation 2.01
|
|
Short-Term Memory Composite Score
Week 8
|
1.56 z-score
Standard Deviation 0.53
|
-0.56 z-score
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
The California Verbal Learning Test (CVLT) is a word list recall task that can be used to test immediate and delayed verbal memory. Free recall after the short delay (immediately after learning lists) and long delay (25 minutes) are reported. Summed z-score ranging from -2 to 2 where higher score indicates better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Executive Function Composite Score
Baseline
|
0.20 z-score
Standard Deviation 1.36
|
-0.10 z-score
Standard Deviation 1.78
|
|
Executive Function Composite Score
Week 8
|
1.66 z-score
Standard Deviation 4.83
|
0.30 z-score
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
The CVLT is a word list recall task that can be used to test immediate and delayed verbal memory. Free recall after long delay (25 minutes). The minimum score is 0. The maximum score is 16 and a higher score represents better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
California Verbal Learning Task (CVLT) Long Delay Free Recall
Baseline
|
12.0 score on a scale
Standard Deviation 4.36
|
10.83 score on a scale
Standard Deviation 3.25
|
|
California Verbal Learning Task (CVLT) Long Delay Free Recall
Week 8
|
12.67 score on a scale
Standard Deviation 2.08
|
13.17 score on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
The CVLT is a word list recall task that can be used to test immediate and delayed verbal memory. Short delay free recall is immediately after learning lists. The minimum score is 0. The maximum score is 16 and a higher score represents better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
CVLT Short Delay Free Recall
Week 8
|
12.33 score on a scale
Standard Deviation 1.15
|
11.67 score on a scale
Standard Deviation 3.93
|
|
CVLT Short Delay Free Recall
Baseline
|
11.67 score on a scale
Standard Deviation 2.08
|
10.00 score on a scale
Standard Deviation 3.91
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
The BVRT tests figural memory by testing memory for a line drawing. The minimum score is 0. The scoring used is total correct, the maximum score is 10, and a higher score represents better performance. The total score is reported.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Benton Visual Retention Task (BVRT) Total Score
Baseline
|
8.67 score on a scale
Standard Deviation 0.58
|
6.5 score on a scale
Standard Deviation 2.07
|
|
Benton Visual Retention Task (BVRT) Total Score
Week 8
|
9.33 score on a scale
Standard Deviation 0.58
|
5.5 score on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
The Prospective Memory test is a test of everyday memory where participants are given instructions for 3 tasks that will occur later on during the testing session. The minimum score is 0. The maximum score is 12 points, a higher score represents better performance, and the total score is reported
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Prospective Memory
Baseline
|
10.67 score on a scale
Standard Deviation 1.53
|
5.83 score on a scale
Standard Deviation 3.97
|
|
Prospective Memory
Week 8
|
10.0 score on a scale
Standard Deviation 2.0
|
8.17 score on a scale
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
Participants were given a letter and asked to say aloud as many words as they could think of beginning with that letter. The three letters were F, A, and S, and the participant had one minute per letter to list words. The total score reported is the sum of the correct words generated for all three letters. Although there is no set maximum score, based on published data, it was anticipated that scores could range from 1 to no more than 120. A higher value reflects better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Verbal Fluency (Letters)
Baseline
|
48.67 number of correct words generated
Standard Deviation 16.50
|
42.67 number of correct words generated
Standard Deviation 9.56
|
|
Verbal Fluency (Letters)
Week 8
|
46.33 number of correct words generated
Standard Deviation 12.58
|
41.33 number of correct words generated
Standard Deviation 7.66
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
Participants were given one minute to say aloud as many fruits as possible and one minute to list as many vegetables as possible. The total score reported is the sum of all correct fruits and vegetables listed. Although there is no set maximum score, it was anticipated that scores could range from 0 to no more than 60. A higher value reflects better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Verbal Fluency Score (Fruits and Vegetables)
Baseline
|
31.0 number of correct fruits and vegetables
Standard Deviation 4.36
|
28.67 number of correct fruits and vegetables
Standard Deviation 8.62
|
|
Verbal Fluency Score (Fruits and Vegetables)
Week 8
|
32.67 number of correct fruits and vegetables
Standard Deviation 7.23
|
29.17 number of correct fruits and vegetables
Standard Deviation 8.28
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
Participants listened to a sequence of two to nine numbers and were asked to repeat each sequence back to the tester in the same order the numbers were presented. The outcome measure reported here is the total number of correct responses (range of scores 0-9). Higher scores reflect better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Digit Span Forward Total Correct
Baseline
|
8.0 number of correct responses
Standard Deviation 0.0
|
7.5 number of correct responses
Standard Deviation 0.55
|
|
Digit Span Forward Total Correct
Week 8
|
7.67 number of correct responses
Standard Deviation 2.08
|
7.67 number of correct responses
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
Participants listened to a sequence of two to nine numbers and were asked to repeat each sequence back to the tester in reverse order. The outcome measure reported here is the longest span of numbers recalled (range of scores 0-9). Higher scores reflect better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Digit Span Backward Total Correct
Week 8
|
6.0 span of numbers recalled
Standard Deviation 1.0
|
5.33 span of numbers recalled
Standard Deviation 2.07
|
|
Digit Span Backward Total Correct
Baseline
|
4.0 span of numbers recalled
Standard Deviation 1.73
|
4.67 span of numbers recalled
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
The Finger Tapping test assesses fine motor speed by asking participants to tap a button as many times as possible. Seven trials were administered. The highest and lowest scores were dropped, and the reported score is the average of the remaining 5 trials. Results for the dominant hand are reported here. There is no set maximum score. However, published averages for women in this age range suggest that a value over 57 would be highly unusual. A higher value (more taps) is better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Finger Tapping Score--Dominant Hand
Baseline
|
40.47 number of taps
Standard Deviation 4.65
|
43.53 number of taps
Standard Deviation 6.45
|
|
Finger Tapping Score--Dominant Hand
Week 8
|
40.27 number of taps
Standard Deviation 2.25
|
44.07 number of taps
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
The Finger Tapping test assesses fine motor speed by asking participants to tap a button as many times as possible. Seven trials were administered. The highest and lowest scores were dropped, and the reported score is the average of the remaining 5 trials. Results for the non-dominant hand are reported here. There is no set maximum score. However, published averages for women in this age range suggest that a value over 57 would be highly unusual. A higher value (more taps) is better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Finger Tapping Score--Non-Dominant Hand
Baseline
|
39.4 number of taps
Standard Deviation 4.1
|
38.2 number of taps
Standard Deviation 5.6
|
|
Finger Tapping Score--Non-Dominant Hand
Week 8
|
42.7 number of taps
Standard Deviation 3.5
|
41.7 number of taps
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Results only reported for subjects who completed study.
The Card Rotations Test is used to assess the ability to mentally rotate figures in space. The test has two parts, each of which last 3 minutes. During each part, the participant is given a sheet of paper with 10 simple geometric figures. Next to each figure is a row of 8 similar figures. Participants are asked to mark whether each of the figures in the row is the same or different than the first figure in the row. The score reported is the number of correct responses. The minimum score is 0. The maximum possible score is 160 and a higher score reflects better performance.
Outcome measures
| Measure |
Post Menopausal Women Without Diabetes
n=3 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=6 Participants
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Card Rotations Test Score
Baseline
|
76.0 score on a scale
Standard Deviation 35.59
|
90.67 score on a scale
Standard Deviation 34.60
|
|
Card Rotations Test Score
Week 8
|
89.33 score on a scale
Standard Deviation 5.86
|
97.0 score on a scale
Standard Deviation 28.71
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: This outcome should have been separated into many other outcomes. So we have separated out all the scores and results will be reported in the other separated memory and executive function score outcomes. No results will be reported in this outcome. Also, rather than "change in", results will be reported as mean/standard deviation in the other outcomes.
A battery of cognitive tasks will be administered before and after estrogen administration. Composite z-scores will be calculated by calculating a z-score for each cognitive task and summing z-scores from -5 (low) to 5 (high) for the tasks designated as short-term memory and executive function.Higher scores denotes better outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 8Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 8Attained from a T2-weighted FLAIR image, an indicator of small-vessel disease correlated with diabetes status and hypertension
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 8Attained from a susceptibility-weighted image
Outcome measures
Outcome data not reported
Adverse Events
Post Menopausal Women Without Diabetes
Post Menopausal Women With Diabetes
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Post Menopausal Women Without Diabetes
n=4 participants at risk
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.
Estradiol patch: transdermal 17β-estradiol patch
|
Post Menopausal Women With Diabetes
n=8 participants at risk
8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes
Estradiol patch: transdermal 17β-estradiol patch
|
|---|---|---|
|
Vascular disorders
Elevated Blood Pressure
|
25.0%
1/4 • Number of events 1 • 8 weeks
|
0.00%
0/8 • 8 weeks
|
|
Reproductive system and breast disorders
Started Period-Like Bleeding/Spotting
|
25.0%
1/4 • Number of events 1 • 8 weeks
|
62.5%
5/8 • Number of events 6 • 8 weeks
|
|
Reproductive system and breast disorders
Breast Tenderness/Soreness
|
50.0%
2/4 • Number of events 2 • 8 weeks
|
25.0%
2/8 • Number of events 2 • 8 weeks
|
|
Reproductive system and breast disorders
Cramping
|
25.0%
1/4 • Number of events 1 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
|
Product Issues
Itching Around Drug Patch
|
25.0%
1/4 • Number of events 1 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/4 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
|
Injury, poisoning and procedural complications
Fall at Home
|
0.00%
0/4 • 8 weeks
|
12.5%
1/8 • Number of events 1 • 8 weeks
|
Additional Information
Christina Hugenschmidt, PhD
Wake Forest University Health Science
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place