Nonalcoholic SteatohepatitisNCT03602573
Liver Fibrosis in Peri-menopausal Women
An observational study of Nonalcoholic Steatohepatitis and Liver Fibroses, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This is a prospective observational study in a single medical center. The aim is to evaluate the status of fibrosis and steatosis of liver parenchyma in peri-menopausal women using noninvasive methods of vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) and serum… Read more about this study
- Who is it for?
- Ages 46 to 55 years, women only
- Conditions the study is for
- Nonalcoholic Steatohepatitis, Liver Fibroses, Menopause
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2018to 31 Jul 2019
- 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 46 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Females, age of 46-55 years, premenopause and postmenopause
Who may be able to join
- Females, age of 46-55 years
- Willing and able to comply with the study requirements
- Willing and able to provide written informed consent to participate in the study
Who cannot join
- Unable to complete the noninvasive procedure of VCET and CAP
- Unwilling to provide written informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Yi-Cheng Chen, MD, 886-3-3281200 ext. 8107, yichengliver@gmail.com
Rong-Nan Chien
About this study
Official title: Nonalcoholic Fatty Liver Disease and Associated Liver Fibrosis in Peri-menopausal Women
This is a prospective observational study in a single medical center.
The aim is to evaluate the status of fibrosis and steatosis of liver parenchyma in peri-menopausal women using noninvasive methods of vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) and serum biomarkers.
Read more
Recruitment period: 2018/08/01 to 2019/07/31
Patient number: 200 females
Inclusion criteria:
- Females, age of 46-55 years
- Willing and able to comply with the study requirements
- Willing and able to provide written informed consent to participate in the study
Exclusion criteria:
- Unable to complete the noninvasive procedure of VCET and CAP
- Unwilling to provide written informed consent to participate in the study
Laboratory tests and examinations:
Baseline and two follow-up visits (every 6 months):
- Blood pressure
- BW, BH, waist circumference, BMI
- Complete blood cell (CBC) count
- Albumin, AST, ALT, alkaline phosphatase, total bilirubin, r-GT, uric acid, hsCRP
- Sugar (fasting), HbA1c, insulin, HOMA-IR
- DM lipid profiles, adiponectin, leptin
- Liver ultrasound, FibroScan touch 520
- FSH, Estrodiol (E2), LH
- TSH, free T4
- HBsAg, anti-HCV, HBV DNA, HCV RNA, HBsAg quantification, HBV genotype (if HBsAg or anti-HCV positive)
- ANA, Anti-mitochondrial antibody
- Review history of drug and menstruation cycles
- Conditions
- Nonalcoholic Steatohepatitis, Liver Fibroses, Menopause
- Keywords
- Nonalcoholic steatohepatitis, Liver fibrosis, Menopause, Hormone
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
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 |
|---|---|---|
| pre-menopause | Not described | |
| post-menopause | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of estrogen level on liver steatosis by FibroScan touch 520
The association of estrogen level with the severity of liver steatosis.
Measured: 1 year
The impact of estrogen level on liver fibrosis by FibroScan touch 520
The association of estrogen level with the severity of liver fibrosis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Aug 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Cheng Chen, Chang Gung Memorial Hospital
- Investigators
- Yi-Cheng Chen, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602573
- Sponsor's protocol ID
- LSM-PMW
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonalcoholic Fatty Liver Disease and Associated Liver Fibrosis in Peri-menopausal Women
- ClinicalTrials.gov ID
- NCT03602573
- Acronym / sponsor ID
- LSM-PMW
- Conditions
- Nonalcoholic Steatohepatitis, Liver Fibroses, Menopause
- Keywords
- Nonalcoholic steatohepatitis, Liver fibrosis, Menopause, Hormone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 27 Jul 2018 (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 prospective observational study in a single medical center.
The aim is to evaluate the status of fibrosis and steatosis of liver parenchyma in peri-menopausal women using noninvasive methods of vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) and serum biomarkers.
Recruitment period: 2018/08/01 to 2019/07/31
Patient number: 200 females
Inclusion criteria:
- Females, age of 46-55 years
- Willing and able to comply with the study requirements
- Willing and able to provide written informed consent to participate in the study
Exclusion criteria:
- Unable to complete the noninvasive procedure of VCET and CAP
- Unwilling to provide written informed consent to participate in the study
Laboratory tests and examinations:
Baseline and two follow-up visits (every 6 months):
- Blood pressure
- BW, BH, waist circumference, BMI
- Complete blood cell (CBC) count
- Albumin, AST, ALT, alkaline phosphatase, total bilirubin, r-GT, uric acid, hsCRP
- Sugar (fasting), HbA1c, insulin, HOMA-IR
- DM lipid profiles, adiponectin, leptin
- Liver ultrasound, FibroScan touch 520
- FSH, Estrodiol (E2), LH
- TSH, free T4
- HBsAg, anti-HCV, HBV DNA, HCV RNA, HBsAg quantification, HBV genotype (if HBsAg or anti-HCV positive)
- ANA, Anti-mitochondrial antibody
- Review history of drug and menstruation cycles
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-menopause | – | – |
| post-menopause | – | – |
Who may qualify
- Ages
- 46 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females, age of 46-55 years, premenopause and postmenopause
Key inclusion criteria (3 listed)
- Females, age of 46-55 years
- Willing and able to comply with the study requirements
- Willing and able to provide written informed consent to participate in the study
Key exclusion criteria (2 listed)
- Unable to complete the noninvasive procedure of VCET and CAP
- Unwilling to provide written informed consent to participate in 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
The impact of estrogen level on liver steatosis by FibroScan touch 520
Time frame: 1 year
The association of estrogen level with the severity of liver steatosis.
The impact of estrogen level on liver fibrosis by FibroScan touch 520
Time frame: 1 year
The association of estrogen level with the severity of liver fibrosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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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.
Yi-Cheng Chen, MD principal investigator
Chang Gung Memorial 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 Nonalcoholic Steatohepatitis and Liver Fibroses, run by Chang Gung Memorial 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 3 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 21 Aug 2018. 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 Yi-Cheng Chen, MD (886-3-3281200 ext. 8107, yichengliver@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of estrogen level on liver steatosis by FibroScan touch 520 (time frame: 1 year). The study lists 2 primary outcomes in all. 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 21 Aug 2018.