Nonalcoholic Fatty Liver DiseaseNCT03847116
Alcohol Consumption and Type 2 Diabetes Mellitus Risk in Nonalcoholic Fatty Liver Disease
An observational study of Nonalcoholic Fatty Liver Disease and Light-to-moderate Alcohol Consumption, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
This study explored the cross-sectional and prospective associations between light-to-moderate alcohol consumption (LMAC) and risk of type 2 diabetes mellitus (T2DM) in individuals with nonalcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Light-to-moderate Alcohol Consumption, Type2 Diabetes Mellitus
- How many people
- 14,014 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2009to 10 Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive Chinese adults underwent annual health examinations in 2009 were enrolled in the cohort study. Follow-up between 2009 and 2018 were obtained in Zhenhai Lianhua Hospital, Ningbo.
Who may be able to join
- aged 18 years or above
- undergoing annual health examinations in 2009 in Zhenhai Lianhua Hospital, Ningbo, China.
- informed about the study
Who cannot join
- female participants;
- missing data on ultrasound, alcohol consumption, and T2DM status;
- alcohol consumption > 210 g per week, and binge drinkers;
- with evidence of other liver diseases including viral hepatitis, autoimmune hepatitis, and drug-induced liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Light-to-moderate Alcohol Consumption With Risk of Type 2 Diabetes Mellitus in Individuals With Nonalcoholic Fatty Liver Disease
This study explored the cross-sectional and prospective associations between light-to-moderate alcohol consumption (LMAC) and risk of type 2 diabetes mellitus (T2DM) in individuals with nonalcoholic fatty liver disease (NAFLD).
- Conditions
- Nonalcoholic Fatty Liver Disease, Light-to-moderate Alcohol Consumption, Type2 Diabetes Mellitus
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Light-to-moderate alcohol consumption (LMAC) and risk of prevalent type 2 diabetes mellitus (T2DM)
Fatty liver was assessed by ultrasound. T2DM was defined as the presence of any of the following conditions based on American Diabetes Association criteria: (1) fasting plasma glucose (FPG) ≥ 7.0 mmol/L; (2) hemoglobin A1c (HbA1c) ≥ 6.5%; (3) self-reported clinician-diagnosed T2DM.
Measured: cross-sectional analyses in 2009
Secondary outcomes (1)
LMAC and incident risk of T2DM
Fatty liver was assessed by ultrasound. T2DM was defined as the presence of any of the following conditions based on American Diabetes Association criteria: (1) fasting plasma glucose (FPG) ≥ 7.0 mmol/L; (2) hemoglobin A1c (HbA1c) ≥ 6.5%; (3) self-reported clinician-diagnosed T2DM.
Measured: 9-year cohort observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Jan 2009
- Primary completion1 Jan 2019
- Study completion10 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- 14,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847116
- Sponsor's protocol ID
- LHNAFLD 2018-V1.0
- Status last verified
- Jul 2019
- First submitted
- 14 Feb 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu L, Xie J, Chen S, Chen Y, Yang H, Miao M, Zhu Z, Li Y, Yu C, Xu C. Light-to-Moderate Alcohol Consumption Is Associated With Increased Risk of Type 2 Diabetes in Individuals With Nonalcoholic Fatty Liver Disease: A Nine-Year Cohort Study. Am J Gastroenterol. 2020 Jun;115(6):876-884. doi: 10.14309/ajg.0000000000000607.
PubMed 32282335
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Light-to-moderate Alcohol Consumption With Risk of Type 2 Diabetes Mellitus in Individuals With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03847116
- Acronym / sponsor ID
- LHNAFLD 2018-V1.0
- Conditions
- Nonalcoholic Fatty Liver Disease, Light-to-moderate Alcohol Consumption, Type2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,014 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 10 Feb 2019 (actual)
- First posted
- 20 Feb 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 study explored the cross-sectional and prospective associations between light-to-moderate alcohol consumption (LMAC) and risk of type 2 diabetes mellitus (T2DM) in individuals with nonalcoholic fatty liver disease (NAFLD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive Chinese adults underwent annual health examinations in 2009 were enrolled in the cohort study. Follow-up between 2009 and 2018 were obtained in Zhenhai Lianhua Hospital, Ningbo.
Key inclusion criteria (3 listed)
- aged 18 years or above
- undergoing annual health examinations in 2009 in Zhenhai Lianhua Hospital, Ningbo, China.
- informed about the study
Key exclusion criteria (4 listed)
- female participants;
- missing data on ultrasound, alcohol consumption, and T2DM status;
- alcohol consumption > 210 g per week, and binge drinkers;
- with evidence of other liver diseases including viral hepatitis, autoimmune hepatitis, and drug-induced liver disease.
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
Light-to-moderate alcohol consumption (LMAC) and risk of prevalent type 2 diabetes mellitus (T2DM)
Time frame: cross-sectional analyses in 2009
Fatty liver was assessed by ultrasound. T2DM was defined as the presence of any of the following conditions based on American Diabetes Association criteria: (1) fasting plasma glucose (FPG) ≥ 7.0 mmol/L; (2) hemoglobin A1c (HbA1c) ≥ 6.5%; (3) self-reported clinician-diagnosed T2DM.
1 secondary outcome
LMAC and incident risk of T2DM
Time frame: 9-year cohort observation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 32282335Xu L, Xie J, Chen S, Chen Y, Yang H, Miao M, Zhu Z, Li Y, Yu C, Xu C. Light-to-Moderate Alcohol Consumption Is Associated With Increased Risk of Type 2 Diabetes in Individuals With Nonalcoholic Fatty Liver Disease: A Nine-Year Cohort Study. Am J Gastroenterol. 2020 Jun;115(6):876-884. doi: 10.14309/ajg.0000000000000607.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fatty Liver Disease and Light-to-moderate Alcohol Consumption, run by Ningbo No. 1 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 3 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: finished, as of the sponsor's last update on 5 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Light-to-moderate alcohol consumption (LMAC) and risk of prevalent type 2 diabetes mellitus (T2DM) (time frame: cross-sectional analyses in 2009). 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 NCT03847116, which also lists 1 linked publication.
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 Jul 2019.