Polycystic Ovary SyndromePULSE-ANCT01775176
Effect of Weight & Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle & Adipose
An observational study of Polycystic Ovary Syndrome, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The overall objective of this ancillary study is to obtain skeletal muscle and subcutaneous adipose tissue biopsies from women with polycystic ovary syndrome enrolled in the PULSE Study (NCT01482286). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Overweight women with polycystic ovary syndrome. 20 - 40 years, inclusive Body mass index ≥ 25kg/m2 History of irregular menstrual cycles (fewer than 8 regular cycles in the past year) Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8) Anovulatory menstrual cycles (determined during screening)
Who may be able to join
- Enrolled in PULSE NCT01482286
Who cannot join
- Withdraw from PULSE NCT01482286
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome: Studies in Skeletal Muscle and Adipose Tissue 'PULSE Ancillary Study'
The overall objective of this ancillary study is to obtain skeletal muscle and subcutaneous adipose tissue biopsies from women with polycystic ovary syndrome enrolled in the PULSE Study (NCT01482286).
Read the detailed description
Muscle and adipose tissues will be appropriately collected and banked for future studies such as to measure expression of candidate genes involved with carbohydrate and fat oxidation and mitochondrial function by RT-PCR, protein content by western blot, enzyme activity by enzymatic assays and to perform functional studies under varying conditions (for example before and after treatment with insulin, testosterone, serum) to quantify insulin signaling and carbohydrate and fat oxidation in primary human cultures.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Weight, Insulin Sensitivity, Reproductive Function
- Medical subject headings
- Polycystic Ovary Syndrome, Body Weight, 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 | Overweight women with polycystic ovary syndrome. 20 - 40 years, inclusiveBody mass index ≥ 25kg/m2History of irregular menstrual cycles (fewer than 8 regular cycles in the past year)Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8)Anovulatory menstrual cycles (determined during screening) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bio specimens for future research
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startMay 2012
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Parent Study stopped due to poor recruitment and enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne M Redman, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775176
- Sponsor's protocol ID
- PBRC 11016-A
- Acronym
- PULSE-A
- Status last verified
- Aug 2021
- First submitted
- 22 Jan 2013
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome: Studies in Skeletal Muscle and Adipose Tissue 'PULSE Ancillary Study'
- ClinicalTrials.gov ID
- NCT01775176
- Acronym / sponsor ID
- PULSE-A / PBRC 11016-A
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Weight, Insulin Sensitivity, Reproductive Function
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Parent Study stopped due to poor recruitment and enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this ancillary study is to obtain skeletal muscle and subcutaneous adipose tissue biopsies from women with polycystic ovary syndrome enrolled in the PULSE Study (NCT01482286).
Detailed description
Muscle and adipose tissues will be appropriately collected and banked for future studies such as to measure expression of candidate genes involved with carbohydrate and fat oxidation and mitochondrial function by RT-PCR, protein content by western blot, enzyme activity by enzymatic assays and to perform functional studies under varying conditions (for example before and after treatment with insulin, testosterone, serum) to quantify insulin signaling and carbohydrate and fat oxidation in primary human cultures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polycystic Ovary Syndrome | – | –Overweight women with polycystic ovary syndrome. 20 - 40 years, inclusiveBody mass index ≥ 25kg/m2History of irregular menstrual cycles (fewer than 8 regular cycles in the past year)Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8)Anovulatory menstrual cycles (determined during screening) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Overweight women with polycystic ovary syndrome. 20 - 40 years, inclusive Body mass index ≥ 25kg/m2 History of irregular menstrual cycles (fewer than 8 regular cycles in the past year) Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8) Anovulatory menstrual cycles (determined during screening)
Key inclusion criteria (1 listed)
- Enrolled in PULSE NCT01482286
Key exclusion criteria (1 listed)
- Withdraw from PULSE NCT01482286
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
Bio specimens for future research
Time frame: 10 years
Results and safety
The study was stopped early (reason given: Parent Study stopped due to poor recruitment and enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
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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.
Leanne M Redman, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Pennington Biomedical Research Center at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Parent Study stopped due to poor recruitment and enrollment). Results are not available in the source record.
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?
Bio specimens for future research (time frame: 10 years). 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 24 Aug 2021.