Brain Metabolism in Polycystic Ovary Syndrome

Completed

• Conditions: Insulin Resistance

• Registration Number: NCT02409914
• Lead Sponsor: Université de Sherbrooke

Brief Summary

The purpose of this study is to investigate whether higher insulin resistance in young women with Polycystic ovary syndrome (PCOS) is associated with reduced cerebral metabolic rate of glucose (CMRglu). Brain volumes using magnetic resonance imaging (MRI) and quantitative cerebral glucose uptake using dynamic positron emission tomography (PET) were obtained.

Detailed Description

MRI and FDG PET scan for each participant were obtained within an average time frame of 3 weeks. Isulin resistance were assessed with the updated homeostasis model assessment (HOMA2-IR).

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2015-03-27
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Results First Submitted: 2017-07-27
• Results First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Results First Posted: 2019-05-02
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

• Diagnosis of PCOS
• Age ≤ 35 y
• BMI ≤ 35

Exclusion Criteria

• Taking medications for diabetes or insulin-sensitizing drugs
• Drug addictions
• Psychiatric illness
• Smoking
• Overt evidence of heart, liver or renal disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin Resistance (HOMA2-IR)	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.
Global Brain Glucose PET Uptake	Single point in time (day 1)	Global brain glucose uptake was quantified using FDG with dynamic positron emission tomography.
Brain MR Volumes	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.