Polycystic Ovary SyndromeNCT02126592
The Secretion of Incretin Hormones in Patients With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by RenJi Hospital at 1 site in China.
Trial summary
Polycystic ovary syndrome (PCOS) is an endocrine disease in reproductive women. It is characterized by anovulation and hyperandrogenism. Most patients with PCOS have metabolic abnormalities such as dyslipidemia, insulin resistance and glucose abnormalities. Read more about this study
- Who is it for?
- Ages 13 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to May 2014
- 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 13 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Polycystic Ovary Syndrome(PCOS)
Who may be able to join
- women at reproductive age
- women with PCOS and women without PCOS
Who cannot join
- young women who had their menarche less than 3 years
- women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, 200001
Jing Ma, Dr., +86-21-68383083, cherry1996@live.cn
About this study
Polycystic ovary syndrome (PCOS) is an endocrine disease in reproductive women. It is characterized by anovulation and hyperandrogenism. Most patients with PCOS have metabolic abnormalities such as dyslipidemia, insulin resistance and glucose abnormalities. Almost 60-80﹪PCOS patients are obesity which exacerbates IR and hyperandrogenism. Obese PCOS patients tend to be overeating suggests that impaired appetite regulation might be contribute to the pathophysiology of PCOS. Our study is trying to observe difference of incretin between PCOS and normal control to figure out whether change of incretin is involved in the pathophysiology of PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
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 |
|---|---|---|
| PCOS cohort | Women with PCOS | |
| Control cohort | Women without PCOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incretin hormones secretion in PCOS patients.
Measured: up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMar 2013
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
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.
- More trials run by RenJi HospitalThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126592
- Sponsor's protocol ID
- 12XJ10015
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Secretion of Incretin Hormones in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02126592
- Acronym / sponsor ID
- 12XJ10015
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 30 Apr 2014 (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.
Polycystic ovary syndrome (PCOS) is an endocrine disease in reproductive women. It is characterized by anovulation and hyperandrogenism. Most patients with PCOS have metabolic abnormalities such as dyslipidemia, insulin resistance and glucose abnormalities. Almost 60-80﹪PCOS patients are obesity which exacerbates IR and hyperandrogenism. Obese PCOS patients tend to be overeating suggests that impaired appetite regulation might be contribute to the pathophysiology of PCOS. Our study is trying to observe difference of incretin between PCOS and normal control to figure out whether change of incretin is involved in the pathophysiology of PCOS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS cohort | – | –Women with PCOS |
| Control cohort | – | –Women without PCOS |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Polycystic Ovary Syndrome(PCOS)
Key inclusion criteria (2 listed)
- women at reproductive age
- women with PCOS and women without PCOS
Key exclusion criteria (2 listed)
- young women who had their menarche less than 3 years
- women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis
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
Change in incretin hormones secretion in PCOS patients.
Time frame: up to 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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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.
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 RenJi Hospital at 1 site in China.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Apr 2014. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Ma, Dr. (+86-21-68383083, cherry1996@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in incretin hormones secretion in PCOS patients. (time frame: up to 14 months). 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 30 Apr 2014.