Polycystic Ovary SyndromeNCT01310569
Subcutaneous Adipose Tissue in Cases With Polycystic Ovarian Syndrome
An observational study of Polycystic Ovary Syndrome, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to search whether whole body and subcutaneous adipose tissues increase in PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2009to Aug 2010
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with PCOS witout any other metabolik diseases
Who may be able to join
- All of the women with PCOS had normal thyroid-stimulating hormone and prolactin (PRL) levels.
Who cannot join
- Subjects with possible ovarian tumors, congenital adrenal hyperplasia, BMI greater than 35 kg/m2, any chronic renal or liver disease, were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, 06100
About this study
Official title: Relationship of Subcutaneous Adipose Tissue With HOMA-IR and Plasma Adiponectin Levels in Cases With Polycystic Ovarian Syndrome
This study aimed to search whether whole body and subcutaneous adipose tissues increase in PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.
Read the detailed description
Fifty-two patients with PCOS and fifty-tree healthy controls who were matched for body mass index (BMI) and age (p=0.430, p=0.112, respectively) were enrolled in the study. Biceps, triceps, subscapular and suprailiac skinfold thicknesses (SFT) of all cases were measured via caliper device; mid-upper arm circumference (MUAC) via a tape; and body fat distributions via a bioelectrical impedance device. Insulin resistance was calculated via HOMA-IR while ELISA was used to measure plasma adiponectin.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Skinfold thickness, HOMA-IR
- Medical subject headings
- Polycystic Ovary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship of Subcutaneous Adipose Tissue with HOMA-IR and Plasma Adiponectin Levels in Cases with Polycystic Ovarian Syndrome
PCOS patients (the experimental group) had higher mean SFT values in all parts, mid-upper arm circumference values, whole body and trunk fat free mass amounts (FFM) and HOMA-IR values, while a lower adiponectin level.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJan 2009
- Primary completionAug 2010
- Study completionAug 2010
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Aydogan Aydogdu, MD, Study director, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310569
- Sponsor's protocol ID
- 27.04.2010/1491-764-10
- Status last verified
- Aug 2010
- First submitted
- 7 Mar 2011
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Subcutaneous Adipose Tissue With HOMA-IR and Plasma Adiponectin Levels in Cases With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT01310569
- Acronym / sponsor ID
- 27.04.2010/1491-764-10
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Skinfold thickness, HOMA-IR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 8 Mar 2011 (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.
This study aimed to search whether whole body and subcutaneous adipose tissues increase in PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.
Detailed description
Fifty-two patients with PCOS and fifty-tree healthy controls who were matched for body mass index (BMI) and age (p=0.430, p=0.112, respectively) were enrolled in the study. Biceps, triceps, subscapular and suprailiac skinfold thicknesses (SFT) of all cases were measured via caliper device; mid-upper arm circumference (MUAC) via a tape; and body fat distributions via a bioelectrical impedance device. Insulin resistance was calculated via HOMA-IR while ELISA was used to measure plasma adiponectin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with PCOS witout any other metabolik diseases
Key inclusion criteria (1 listed)
- All of the women with PCOS had normal thyroid-stimulating hormone and prolactin (PRL) levels.
Key exclusion criteria (1 listed)
- Subjects with possible ovarian tumors, congenital adrenal hyperplasia, BMI greater than 35 kg/m2, any chronic renal or liver disease, were excluded from the study.
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
Relationship of Subcutaneous Adipose Tissue with HOMA-IR and Plasma Adiponectin Levels in Cases with Polycystic Ovarian Syndrome
Time frame: 2 year
PCOS patients (the experimental group) had higher mean SFT values in all parts, mid-upper arm circumference values, whole body and trunk fat free mass amounts (FFM) and HOMA-IR values, while a lower adiponectin level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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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.
Aydogan Aydogdu, MD study director
Gulhane School of Medicine
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 Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 8 Mar 2011. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship of Subcutaneous Adipose Tissue with HOMA-IR and Plasma Adiponectin Levels in Cases with Polycystic Ovarian Syndrome (time frame: 2 year). 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 8 Mar 2011.