Polycystic Ovary SyndromeNCT04151459
Effect of Metabolic Surgery on Live Birth Rate of Offspring in Obesity Polycystic Ovarian Syndrome Patients
A study testing Metformin in people with Polycystic Ovary Syndrome and Severe Obesity, run by RenJi Hospital at 1 site in China.
Trial summary
This is a experimental study, which subjects are obese PCOS patients requiring LSG surgery. Aim to investigate the effects of LSG surgery in PCOS patients whether increases the live birth rate of the offspring. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Severe Obesity, Laparoscopic Sleeve Gastrectomy
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2019to 15 Jan 2022
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- aged from 18 to 45, not menopause have PCOS which is diagnosed according to 2003 Rotterdam criteria have been treated with behavioral and drugs intervention for 3 months but are ineffective have steady or steady weight gain over 5 years, BMI>35kg/m2, or BMI>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome
Who cannot join
- Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months) high blood pressure (>160/100mmHg) active infection secondary diabetes pregnancy alcohol abuse surgical contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200127
Tao Tao, Doctor, +86-13817701776, taotaozhen@hotmail.com
About this study
Official title: Effect of Laparoscopic Sleeve Gastrectomy (LSG) on Live Birth Rate of Offspring in Polycystic Ovarian Syndrome (PCOS) Patients With Severely Obese
This is a experimental study, which subjects are obese PCOS patients requiring LSG surgery. Aim to investigate the effects of LSG surgery in PCOS patients whether increases the live birth rate of the offspring.
Read the detailed description
The investigators designed a single center small sample exploratory study to clear the therapeutic effects of laparoscopic sleeve gastrectomy on live birth rate improvements of overweight/obese PCOS patients. The investigators plan to enroll 18 patients. Inclusion criteria: 1) Patients who are aged from 18 to 45, not menopause;2) have PCOS which is diagnosed according to 2003 Rotterdam criteria; 3) have been treated with behavioral and drugs intervention for 3 months but are ineffective; 4) have steady or steady weight gain over 5 years, BMI>35kg/m2, or BMI>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome.
Patients with serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months); high blood pressure (>160/100mmHg); active infection; secondary diabetes; pregnancy; alcohol abuse; surgical contraindications are excluded.
Then the investigators plan to perform laparoscopic sleeve gastrectomy . Before and after the intervention, the blood samples would be collected to detect blood glucose, insulin, lipid profile, sex hormones, blood chemistry for liver and kidney function, hsCRP etc., as well as the anthropometric measurement and image examinations. All patients are followed up every 3 months until the end of the program. All patients receive MRI plain scan of upper and lower abdomen, oral glucose tolerance test (OGTT) and insulin, C-peptide releasing test again every 6 months after the operation. One year after the operation, patients would be evaluated whether they are suitable for pregnancy preparation and record the pregnancy mode. After pregnancy, various indicators would be closely monitored, including maternal vitamin and trace element levels.The birth of children and the live birth rate would be recorded.
The investigators will compare the data and finally identify the treatment effect of laparoscopic sleeve gastrectomy on overweight/obese PCOS patients.
- Being tested
- Metformin
- Keywords
- Polycystic Ovary Syndrome, Severe Obesity, Laparoscopic Sleeve Gastrectomy, Live Birth Rate
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Use Metformin for 3 months to treat PCOS
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Experimental | Laparoscopic sleeve gastrectomy on severe obesity PCOS patients Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of metabolic surgery on live birth rate of offspring in obesity PCOS patients.
To record the offspring production and live birth rate of obesity PCOS patients after metabolic surgery
Measured: up to 3 years
Secondary outcomes (2)
Effect of metabolic surgery on ovulation rate and pregnancy rate of PCOS patients
To compare the ovulation rate and pregnancy of obesity PCOS patient with metabolic surgery or not
Measured: up to 3 years
Effects of metabolic surgery on intestinal flora of PCOS patients and progeny.
To compare the intestinal flora of PCOS patients after metabolic surgery
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start16 Jan 2019
- Primary completion15 Jan 2022 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Tao, MD, Study chair, RenJi Hospital Department of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151459
- Sponsor's protocol ID
- [2018]048
- Status last verified
- Nov 2019
- First submitted
- 15 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li R, Zhang Q, Yang D, Li S, Lu S, Wu X, Wei Z, Song X, Wang X, Fu S, Lin J, Zhu Y, Jiang Y, Feng HL, Qiao J. Prevalence of polycystic ovary syndrome in women in China: a large community-based study. Hum Reprod. 2013 Sep;28(9):2562-9. doi: 10.1093/humrep/det262. Epub 2013 Jun 27.
PubMed 23814096Jarrett BY, Lujan ME. Impact of hypocaloric dietary intervention on ovulation in obese women with PCOS. Reproduction. 2017 Jan;153(1):R15-R27. doi: 10.1530/REP-16-0385.
PubMed 27799625Behboudi-Gandevani S, Ramezani Tehrani F, Rostami Dovom M, Farahmand M, Bahri Khomami M, Noroozzadeh M, Kabir A, Azizi F. Insulin resistance in obesity and polycystic ovary syndrome: systematic review and meta-analysis of observational studies. Gynecol Endocrinol. 2016;32(5):343-53. doi: 10.3109/09513590.2015.1117069. Epub 2016 Jan 6.
PubMed 27052492Skubleny D, Switzer NJ, Gill RS, Dykstra M, Shi X, Sagle MA, de Gara C, Birch DW, Karmali S. The Impact of Bariatric Surgery on Polycystic Ovary Syndrome: a Systematic Review and Meta-analysis. Obes Surg. 2016 Jan;26(1):169-76. doi: 10.1007/s11695-015-1902-5.
PubMed 26431698Niu Z, Lin N, Gu R, Sun Y, Feng Y. Associations between insulin resistance, free fatty acids, and oocyte quality in polycystic ovary syndrome during in vitro fertilization. J Clin Endocrinol Metab. 2014 Nov;99(11):E2269-76. doi: 10.1210/jc.2013-3942. Epub 2014 Apr 2.
PubMed 24694334Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.
PubMed 24880830
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laparoscopic Sleeve Gastrectomy (LSG) on Live Birth Rate of Offspring in Polycystic Ovarian Syndrome (PCOS) Patients With Severely Obese
- ClinicalTrials.gov ID
- NCT04151459
- Acronym / sponsor ID
- [2018]048
- Keywords
- Polycystic Ovary Syndrome, Severe Obesity, Laparoscopic Sleeve Gastrectomy, Live Birth Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 15 Jan 2022 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 5 Nov 2019 (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.
This is a experimental study, which subjects are obese PCOS patients requiring LSG surgery. Aim to investigate the effects of LSG surgery in PCOS patients whether increases the live birth rate of the offspring.
Detailed description
The investigators designed a single center small sample exploratory study to clear the therapeutic effects of laparoscopic sleeve gastrectomy on live birth rate improvements of overweight/obese PCOS patients. The investigators plan to enroll 18 patients. Inclusion criteria: 1) Patients who are aged from 18 to 45, not menopause;2) have PCOS which is diagnosed according to 2003 Rotterdam criteria; 3) have been treated with behavioral and drugs intervention for 3 months but are ineffective; 4) have steady or steady weight gain over 5 years, BMI>35kg/m2, or BMI>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome.
Patients with serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months); high blood pressure (>160/100mmHg); active infection; secondary diabetes; pregnancy; alcohol abuse; surgical contraindications are excluded.
Then the investigators plan to perform laparoscopic sleeve gastrectomy . Before and after the intervention, the blood samples would be collected to detect blood glucose, insulin, lipid profile, sex hormones, blood chemistry for liver and kidney function, hsCRP etc., as well as the anthropometric measurement and image examinations. All patients are followed up every 3 months until the end of the program. All patients receive MRI plain scan of upper and lower abdomen, oral glucose tolerance test (OGTT) and insulin, C-peptide releasing test again every 6 months after the operation. One year after the operation, patients would be evaluated whether they are suitable for pregnancy preparation and record the pregnancy mode. After pregnancy, various indicators would be closely monitored, including maternal vitamin and trace element levels.The birth of children and the live birth rate would be recorded.
The investigators will compare the data and finally identify the treatment effect of laparoscopic sleeve gastrectomy on overweight/obese PCOS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Experimental | Drug: MetforminLaparoscopic sleeve gastrectomy on severe obesity PCOS patients |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- aged from 18 to 45, not menopause have PCOS which is diagnosed according to 2003 Rotterdam criteria have been treated with behavioral and drugs intervention for 3 months but are ineffective have steady or steady weight gain over 5 years, BMI>35kg/m2, or BMI>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome
Key exclusion criteria (1 listed)
- Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months) high blood pressure (>160/100mmHg) active infection secondary diabetes pregnancy alcohol abuse surgical contraindications
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 |
|---|---|---|
| MetforminAlso: GlucophageUse Metformin for 3 months to treat PCOS | Drug | Laparoscopic sleeve gastrectomy |
Primary outcome
Improvement of metabolic surgery on live birth rate of offspring in obesity PCOS patients.
Time frame: up to 3 years
To record the offspring production and live birth rate of obesity PCOS patients after metabolic surgery
2 secondary outcomes
Effect of metabolic surgery on ovulation rate and pregnancy rate of PCOS patients
Time frame: up to 3 years
Effects of metabolic surgery on intestinal flora of PCOS patients and progeny.
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Background: PubMed 23814096Li R, Zhang Q, Yang D, Li S, Lu S, Wu X, Wei Z, Song X, Wang X, Fu S, Lin J, Zhu Y, Jiang Y, Feng HL, Qiao J. Prevalence of polycystic ovary syndrome in women in China: a large community-based study. Hum Reprod. 2013 Sep;28(9):2562-9. doi: 10.1093/humrep/det262. Epub 2013 Jun 27.
- Background: PubMed 27799625Jarrett BY, Lujan ME. Impact of hypocaloric dietary intervention on ovulation in obese women with PCOS. Reproduction. 2017 Jan;153(1):R15-R27. doi: 10.1530/REP-16-0385.
- Background: PubMed 27052492Behboudi-Gandevani S, Ramezani Tehrani F, Rostami Dovom M, Farahmand M, Bahri Khomami M, Noroozzadeh M, Kabir A, Azizi F. Insulin resistance in obesity and polycystic ovary syndrome: systematic review and meta-analysis of observational studies. Gynecol Endocrinol. 2016;32(5):343-53. doi: 10.3109/09513590.2015.1117069. Epub 2016 Jan 6.
- Background: PubMed 26431698Skubleny D, Switzer NJ, Gill RS, Dykstra M, Shi X, Sagle MA, de Gara C, Birch DW, Karmali S. The Impact of Bariatric Surgery on Polycystic Ovary Syndrome: a Systematic Review and Meta-analysis. Obes Surg. 2016 Jan;26(1):169-76. doi: 10.1007/s11695-015-1902-5.
- Background: PubMed 24694334Niu Z, Lin N, Gu R, Sun Y, Feng Y. Associations between insulin resistance, free fatty acids, and oocyte quality in polycystic ovary syndrome during in vitro fertilization. J Clin Endocrinol Metab. 2014 Nov;99(11):E2269-76. doi: 10.1210/jc.2013-3942. Epub 2014 Apr 2.
- Background: PubMed 24880830Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.
- 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 study chair
RenJi Hospital Department of Endocrinology and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Polycystic Ovary Syndrome and Severe Obesity, 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 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: status not confirmed, as of the sponsor's last update on 5 Nov 2019. 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 Tao Tao, MD (+86-13817701776, taotaozhen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of metabolic surgery on live birth rate of offspring in obesity PCOS patients. (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151459, which also lists 6 linked publications.
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 5 Nov 2019.