Insulin ResistanceNCT02409914
Brain Metabolism in Polycystic Ovary Syndrome
An observational study of Insulin Resistance, run by Université de Sherbrooke.
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Insulin Resistance
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Sep 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with PCOS (n=7) were referred by physician specialist in endocrinology between March, 2010 and September, 2013. The diagnosis of PCOS was based on clinical examination using the Rotterdam criteria.
Who may be able to join
- Diagnosis of PCOS
- Age ≤ 35 y
- BMI ≤ 35
Who cannot join
- Taking medications for diabetes or insulin-sensitizing drugs
- Drug addictions
- Psychiatric illness
- Smoking
- Overt evidence of heart, liver or renal disease
About this study
Official title: Brain Metabolism in Women With Polycystic Ovary Syndrome: a PET/MRI Study
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.
Read the 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).
- Conditions
- Insulin Resistance
- Keywords
- Insulin Resistance, Brain metabolism, PET, MRI
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| POLYCYSTIC OVARY SYNDROME (PCOS) | FDG PET scan,T1-weight MRI and blood were obtained for each participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Brain Glucose PET Uptake
Global brain glucose uptake was quantified using FDG with dynamic positron emission tomography.
Measured: Single point in time (day 1)
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.
Measured: Single point in time (day 2)
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.
Measured: Single point in time (day 1 during the FDG PET)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startMar 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409914
- Sponsor's protocol ID
- 10-153
- Status last verified
- Apr 2015
- First submitted
- 27 Mar 2015
- Last updated
- 2 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Metabolism in Women With Polycystic Ovary Syndrome: a PET/MRI Study
- ClinicalTrials.gov ID
- NCT02409914
- Acronym / sponsor ID
- 10-153
- Conditions
- Insulin Resistance
- Keywords
- Insulin Resistance, Brain metabolism, PET, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 2 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POLYCYSTIC OVARY SYNDROME (PCOS) | – | –FDG PET scan,T1-weight MRI and blood were obtained for each participant |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with PCOS (n=7) were referred by physician specialist in endocrinology between March, 2010 and September, 2013. The diagnosis of PCOS was based on clinical examination using the Rotterdam criteria.
Key inclusion criteria (3 listed)
- Diagnosis of PCOS
- Age ≤ 35 y
- BMI ≤ 35
Key exclusion criteria (5 listed)
- Taking medications for diabetes or insulin-sensitizing drugs
- Drug addictions
- Psychiatric illness
- Smoking
- Overt evidence of heart, liver or renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global Brain Glucose PET Uptake
Time frame: Single point in time (day 1)
Global brain glucose uptake was quantified using FDG with dynamic positron emission tomography.
Brain MR Volumes
Time frame: 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.
Insulin Resistance (HOMA2-IR)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Brain Glucose PET Uptake (time frame: Single point in time (day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.