Brain Metabolism in Polycystic Ovary Syndrome

Insulin Resistance Clinical Trial

Official title:

Brain Metabolism in Women With Polycystic Ovary Syndrome: a PET/MRI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409914
• Other study ID #: 10-153
• Status: Completed
• Start date: March 2010
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Brain Glucose PET Uptake	Global brain glucose uptake was quantified using FDG with dynamic positron emission tomography.	Single point in time (day 1)
Primary	Brain MR Volumes	T1-weighted brain MR images were obtained on a 1.5 Tesla scanner. Regional volumes were determined using FreeSurfer Suite 5.0 software.	Single point in time (day 2)
Primary	Insulin Resistance (HOMA2-IR)	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.	Single point in time (day 1 during the FDG PET)