Trial Outcomes & Findings for Brain Metabolism in Polycystic Ovary Syndrome (NCT NCT02409914)
NCT ID: NCT02409914
Last Updated: 2019-05-02
Results Overview
Global brain glucose uptake was quantified using FDG with dynamic positron emission tomography.
COMPLETED
7 participants
Single point in time (day 1)
2019-05-02
Participant Flow
Women with PCOS diagnosed during a clinical examination using the Rotterdam criteria were recruited.
Participant milestones
| Measure |
POLYCYSTIC OVARY SYNDROME (PCOS)
Women with PCOS. FDG PET scan,T1-weight MRI and a blood sample for the evaluation of insulin resistance were obtained within an average time frame of 3 weeks.
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|---|---|
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Overall Study
STARTED
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7
|
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Overall Study
COMPLETED
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7
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Metabolism in Polycystic Ovary Syndrome
Baseline characteristics by cohort
| Measure |
POLYCYSTIC OVARY SYNDROME (PCOS)
n=7 Participants
Women with PCOS diagnosed during a clinical examination using the Rotterdam criteria.
PET and MRI exams: FDG PET scan and T1-weight MRI were obtained within an average time frame of 3 weeks.
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|---|---|
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Age, Continuous
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25 years
STANDARD_DEVIATION 6 • n=5 Participants
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Sex: Female, Male
Female
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7 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Single point in time (day 1)Global brain glucose uptake was quantified using FDG with dynamic positron emission tomography.
Outcome measures
| Measure |
Polycystic Ovary Syndrome (PCOS)
n=7 Participants
Women with PCOS.
|
|---|---|
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Global Brain Glucose PET Uptake
|
34.9 umol/100 g/min
Standard Deviation 3.0
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PRIMARY outcome
Timeframe: Single point in time (day 2)T1-weighted brain MR images were obtained on a 1.5 Tesla scanner. Regional volumes were determined using FreeSurfer Suite 5.0 software.
Outcome measures
| Measure |
Polycystic Ovary Syndrome (PCOS)
n=7 Participants
Women with PCOS.
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|---|---|
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Brain MR Volumes
Superior frontal cortex
|
22.6 ml
Standard Deviation 2.0
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Brain MR Volumes
Supramarginal cortex
|
10.3 ml
Standard Deviation 1.4
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PRIMARY outcome
Timeframe: Single point in time (day 1 during the FDG PET)The homeostasis model assessment computational method was used to estimate insulin resistance (HOMA2-IR) from fasting plasma glucose and insulin. The HOMA2-IR is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (normal young adult). A higher score indicates a lower insulin sensitivity.
Outcome measures
| Measure |
Polycystic Ovary Syndrome (PCOS)
n=7 Participants
Women with PCOS.
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|---|---|
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Insulin Resistance (HOMA2-IR)
|
0.7 HOMA2-IR score
Standard Deviation 0.3
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Adverse Events
POLYCYSTIC OVARY SYNDROME (PCOS)
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