PCOSPhase 4PCOSNCT03383068
Research of Intensive Metabolic Intervention Before Pregnancy in PCOS
A Phase 4 study testing Acarbose 100 MG, Exenatide and Orlistat in people with PCOS and Impaired Glucose Tolerance, run by RenJi Hospital at 1 site in China.
Trial summary
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women at childbearing age. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- PCOS, Impaired Glucose Tolerance
- What is being tested?
- Acarbose 100 MG, Exenatide and Orlistat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Jun 2020
- Phase
- Phase 4
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS women at Childbearing Age
- PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the 2003 Rotterdam criteria.
Who cannot join
- Past or present history of a medical disorder or medication known to affect body composition, insulin secretion and sensitivity, or the growth hormone (GH)-insulin-like growth factor 1 (IGF1) axis (eg steroid hormone or thyroid replacement).
- History of current or past pregnancy
- Hormonal contraceptive or metformin use within 3 months of enrollment
- Nonclassical congenital adrenal hyperplasia
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital Department of Endocrinology and Metabolism
Shanghai, Shanghai Municipality, 200127
Wei Liu, MD, +86-18918358342, sue_liuwei@163.com
About this study
Official title: Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.
Read the detailed description
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women with IGR / DM not effective of metformin treatment at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.
- Conditions
- PCOS, Impaired Glucose Tolerance
- Being tested
- Acarbose 100 MG, Exenatide, Orlistat, Metformin
- Keywords
- PCOS, imparied glucose tolerance
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acarbose 100 MGDrug
Also called Acarbose
for metformin uneffective subjects, using acarbose for 3 months
ExenatideDrug
for metformin uneffective subjects, using Exenatide for 3 months
OrlistatDrug
for metformin uneffective subjects, using Orlistatfor 3 months
MetforminDrug
Also called METF
metformin effective subjects,act as control group
| Study group | Role | What they receive |
|---|---|---|
| control | Other | metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance Receives: Drug: Metformin |
| acarbose | Experimental | metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with acarbose (100mg tid ) for 3 months Receives: Drug: Acarbose 100 MG |
| Exenatide | Experimental | metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Exenatide 10μg/bid ) for 3 months Receives: Drug: Exenatide |
| Orlistat | Experimental | metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Orlistat(0.12mg/tid ) for 3 months Receives: Drug: Orlistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of pregnant rate after intensive metabolic intervention
To compare the pregnant rate of four groups after treatment
Measured: up to 24 weeks
Secondary outcomes (5)
Improvement of obsorbtion rate after intensive metabolic intervention
To compare the obsorbtion rate of four groups after treatment
Measured: up to 24 weeks
Improvement of stillborn foetus rate after intensive metabolic intervention
To compare the stillborn foetus rate of four groups after treatment
Measured: up to 24 weeks
Improvement of hyperandrogenism
To compare the free androgen index of three groups after treatment
Measured: up to 24 weeks
Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation
To compare the intravenous blood glucose of three groups after treatment
Measured: up to 24 weeks
Improvement of triglyceride
To compare the circulating triglyceride of three groups after treatment
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Tao, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383068
- Sponsor's protocol ID
- [2017]055
- Acronym
- PCOS
- Status last verified
- Dec 2017
- First submitted
- 28 Nov 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03383068
- Acronym / sponsor ID
- PCOS / [2017]055
- Conditions
- PCOS, Impaired Glucose Tolerance
- Keywords
- PCOS, imparied glucose tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 26 Dec 2017 (actual)
- 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.
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.
Detailed description
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women with IGR / DM not effective of metformin treatment at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | Other | Drug: Metforminmetformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance |
| acarbose | Experimental | Drug: Acarbose 100 MGmetformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with acarbose (100mg tid ) for 3 months |
| Exenatide | Experimental | Drug: Exenatidemetformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Exenatide 10μg/bid ) for 3 months |
| Orlistat | Experimental | Drug: Orlistatmetformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Orlistat(0.12mg/tid ) for 3 months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- PCOS women at Childbearing Age
- PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the 2003 Rotterdam criteria.
Key exclusion criteria (4 listed)
- Past or present history of a medical disorder or medication known to affect body composition, insulin secretion and sensitivity, or the growth hormone (GH)-insulin-like growth factor 1 (IGF1) axis (eg steroid hormone or thyroid replacement).
- History of current or past pregnancy
- Hormonal contraceptive or metformin use within 3 months of enrollment
- Nonclassical congenital adrenal hyperplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acarbose 100 MGAlso: Acarbosefor metformin uneffective subjects, using acarbose for 3 months | Drug | acarbose |
| Exenatidefor metformin uneffective subjects, using Exenatide for 3 months | Drug | Exenatide |
| Orlistatfor metformin uneffective subjects, using Orlistatfor 3 months | Drug | Orlistat |
| MetforminAlso: METFmetformin effective subjects,act as control group | Drug | control |
Primary outcome
Improvement of pregnant rate after intensive metabolic intervention
Time frame: up to 24 weeks
To compare the pregnant rate of four groups after treatment
5 secondary outcomes
Improvement of obsorbtion rate after intensive metabolic intervention
Time frame: up to 24 weeks
Improvement of stillborn foetus rate after intensive metabolic intervention
Time frame: up to 24 weeks
Improvement of hyperandrogenism
Time frame: up to 24 weeks
Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation
Time frame: up to 24 weeks
Improvement of triglyceride
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Tao Tao, MD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acarbose 100 MG, Exenatide and Orlistat in people with PCOS and Impaired Glucose Tolerance, 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 4 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 26 Dec 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tao Tao, MD (86-13817701776, taotaosh76@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of pregnant rate after intensive metabolic intervention (time frame: up to 24 weeks). 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 26 Dec 2017.