ObesityNCT04275674
Inflammasome Activation and Cortisol Metabolism in Obese Women With Recurrent Miscarriage
An observational study of Obesity and Inflammation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The prevalence of obesity among women of reproductive age is increasing. Obesity represents a chronic low-grade inflammatory state and NLRP3 inflammasome plays a pivotal role in obesity-induced inflammation. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammation
- How many people
- 57 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to Jul 2023
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Cases were referred for 200 women who have experienced at least two consecutive miscarriages are recruited from outpatient clinics of our hospital, including at least 50 obese women
Who may be able to join
- All women have conceived naturally without the aid of assisted reproductive technologies
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 70428
Pao-Lin Kuo, MD, 886-6-2353535 ext. 5262, paolink@mail.ncku.edu.tw
Pao-Lin Kuo, MD
About this study
Official title: Dr. Pao-Lin Kuo (Department of Obstetrics and Gynecology
The prevalence of obesity among women of reproductive age is increasing. Obesity represents a chronic low-grade inflammatory state and NLRP3 inflammasome plays a pivotal role in obesity-induced inflammation. Obesity is associated with an increased risk of recurrent miscarriage (RM), but the underlying mechanisms are unclear. Abnormal inflammasome activation was also identified in the endometrium of women who experienced RM. Given inflammasome activation has emerged as common pathophysiology in obesity-related disorder and RM, the investigators wonder whether inflammasome activation occurs in the uterine macrophages of obese women, and result in early reproductive failure.
Read the detailed description
pending
- Conditions
- Obesity, Inflammation
- Medical subject headings
- Obesity, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of inflammatory markers
Use the levels of hsCRP and CA125 provides the information about inflammation.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Aug 2017
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pao-Lin Kuo, MD, Principal investigator, Department of Obstetrics and Gynecology, National Cheng Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275674
- Sponsor's protocol ID
- A-ER-105-481
- Status last verified
- Sep 2022
- First submitted
- 28 Oct 2019
- Last updated
- 4 Oct 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dr. Pao-Lin Kuo (Department of Obstetrics and Gynecology
- ClinicalTrials.gov ID
- NCT04275674
- Acronym / sponsor ID
- A-ER-105-481
- Conditions
- Obesity, Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 19 Feb 2020 (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.
The prevalence of obesity among women of reproductive age is increasing. Obesity represents a chronic low-grade inflammatory state and NLRP3 inflammasome plays a pivotal role in obesity-induced inflammation. Obesity is associated with an increased risk of recurrent miscarriage (RM), but the underlying mechanisms are unclear. Abnormal inflammasome activation was also identified in the endometrium of women who experienced RM. Given inflammasome activation has emerged as common pathophysiology in obesity-related disorder and RM, the investigators wonder whether inflammasome activation occurs in the uterine macrophages of obese women, and result in early reproductive failure.
Detailed description
pending
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cases were referred for 200 women who have experienced at least two consecutive miscarriages are recruited from outpatient clinics of our hospital, including at least 50 obese women
Key inclusion criteria (1 listed)
- All women have conceived naturally without the aid of assisted reproductive technologies
Key exclusion criteria (1 listed)
- N/A
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
Validity of inflammatory markers
Time frame: 1 Day
Use the levels of hsCRP and CA125 provides the information about inflammation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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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.
Pao-Lin Kuo, MD principal investigator
Department of Obstetrics and Gynecology, National Cheng Kung University Hospital
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 Obesity and Inflammation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 4 Oct 2022. 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 Taiwan. 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 Pao-Lin Kuo, MD (886-6-2353535 ext. 5262, paolink@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of inflammatory markers (time frame: 1 Day). 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 4 Oct 2022.