Nonalcoholic Fatty Liver DiseaseNCT05550688
Weight Gain After Smoking Cessation and NAFLD
An observational study of Nonalcoholic Fatty Liver Disease and Type 2 Diabetes, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common chronic liver disease. Considering that there are no approved pharmacological treatments, lifestyle modification is necessary and challenging to reduce the risk of type 2 diabetes mellitus (T2DM) in patients with 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, Type 2 Diabetes
- How many people
- 12,941 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2007to 1 Aug 2022
- 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: The investigators enrolled participants who took annual health examinations at Zhenhai Lianhua Hospital in 2007.
Who may be able to join
- age>=18 years.
Who cannot join
- with missing information on ultrasound, smoking status, and weight; (ii) with excess alcohol intake or history of chronic liver disease at baseline; (iii) female subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Weight Gain After Smoking Cessation Increased the Risk of Type 2 Diabetes in Individuals With Nonalcoholic Fatty Liver Disease
Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common chronic liver disease. Considering that there are no approved pharmacological treatments, lifestyle modification is necessary and challenging to reduce the risk of type 2 diabetes mellitus (T2DM) in patients with NAFLD.
Cigarette smoking has a significant negative impact on public health, causing more than 480,000 deaths each year. Smoking has been reported as a risk factor for NAFLD and might accelerate liver disease progression. Therefore, it is recommended that patients with NAFLD quit smoking. However, smoking cessation could be complicated by weight gain. Thus, it is important to assess the impact of weight change after smoking cessation on patients with NAFLD. Proper management of post-cessation weight could maximize its health benefits.
In this large-scale cohort study, the investigators aimed to assess the effects of smoking cessation and subsequent weight change on risks of incident T2DM in individuals with NAFLD.
- Conditions
- Nonalcoholic Fatty Liver Disease, Type 2 Diabetes
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
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 |
|---|---|---|
| NAFLD and NAFLD-free cohort | The investigators diagnosed nonalcoholic fatty liver based on abdominal ultrasonography and ruled out excessive alcohol consumption and other etiologies of liver disease according to the Chinese Liver Disease Association. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change after smoking cessation on incident T2DM in NAFLD individuals
The investigators used Cox proportional hazard models to estimate hazard ratios (HRs) and 95% CIs for the associations of weight change during smoking cessation with the incidence of T2DM. The investigators did not find any evidence of violation of the proportional hazard assumption. In multivariable models, the investigators constructed three nested models for analysis: (i) model 1 adjusted for age, and body mass index; (ii) model 2, model 1 plus drinking status; (iii) model 3, model 2 plus aspartate aminotransferase, total cholesterol, triacylglycerol, creatinine, albumin, and systolic blood pressure.
Measured: a 7-year cohort study
Weight Change after smoking cessation on incident T2DM in NAFLD-free individuals
The investigators used Cox proportional hazard models to estimate hazard ratios (HRs) and 95% CIs for the associations of weight change during smoking cessation with the incidence of T2DM. The investigators did not find any evidence of violation of the proportional hazard assumption. In multivariable models, the investigators constructed three nested models for analysis: (i) model 1 adjusted for age, and body mass index; (ii) model 2, model 1 plus drinking status; (iii) model 3, model 2 plus aspartate aminotransferase, total cholesterol, triacylglycerol, creatinine, albumin, and systolic blood pressure.
Measured: a 7-year cohort study
Secondary outcomes (1)
Mediation analysis of smoking relapse on incident T2DM
The investigators conducted a mediation analysis to assess whether the association between smoking status and NAFLD was mediated by smoking relapse.
Measured: a 7-year cohort study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Jan 2007
- Primary completion31 Dec 2014
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 12,941 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
- NCT05550688
- Sponsor's protocol ID
- NAFLD_quitsmoking
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Weight Gain After Smoking Cessation Increased the Risk of Type 2 Diabetes in Individuals With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05550688
- Acronym / sponsor ID
- NAFLD_quitsmoking
- Conditions
- Nonalcoholic Fatty Liver Disease, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,941 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 22 Sep 2022 (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.
Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common chronic liver disease. Considering that there are no approved pharmacological treatments, lifestyle modification is necessary and challenging to reduce the risk of type 2 diabetes mellitus (T2DM) in patients with NAFLD.
Cigarette smoking has a significant negative impact on public health, causing more than 480,000 deaths each year. Smoking has been reported as a risk factor for NAFLD and might accelerate liver disease progression. Therefore, it is recommended that patients with NAFLD quit smoking. However, smoking cessation could be complicated by weight gain. Thus, it is important to assess the impact of weight change after smoking cessation on patients with NAFLD. Proper management of post-cessation weight could maximize its health benefits.
In this large-scale cohort study, the investigators aimed to assess the effects of smoking cessation and subsequent weight change on risks of incident T2DM in individuals with NAFLD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAFLD and NAFLD-free cohort | – | –The investigators diagnosed nonalcoholic fatty liver based on abdominal ultrasonography and ruled out excessive alcohol consumption and other etiologies of liver disease according to the Chinese Liver Disease Association. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators enrolled participants who took annual health examinations at Zhenhai Lianhua Hospital in 2007.
Key inclusion criteria (1 listed)
- age>=18 years.
Key exclusion criteria (1 listed)
- with missing information on ultrasound, smoking status, and weight; (ii) with excess alcohol intake or history of chronic liver disease at baseline; (iii) female subjects.
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
Weight Change after smoking cessation on incident T2DM in NAFLD individuals
Time frame: a 7-year cohort study
The investigators used Cox proportional hazard models to estimate hazard ratios (HRs) and 95% CIs for the associations of weight change during smoking cessation with the incidence of T2DM. The investigators did not find any evidence of violation of the proportional hazard assumption. In multivariable models, the investigators constructed three nested models for analysis: (i) model 1 adjusted for age, and body mass index; (ii) model 2, model 1 plus drinking status; (iii) model 3, model 2 plus aspartate aminotransferase, total cholesterol, triacylglycerol, creatinine, albumin, and systolic blood pressure.
Weight Change after smoking cessation on incident T2DM in NAFLD-free individuals
Time frame: a 7-year cohort study
The investigators used Cox proportional hazard models to estimate hazard ratios (HRs) and 95% CIs for the associations of weight change during smoking cessation with the incidence of T2DM. The investigators did not find any evidence of violation of the proportional hazard assumption. In multivariable models, the investigators constructed three nested models for analysis: (i) model 1 adjusted for age, and body mass index; (ii) model 2, model 1 plus drinking status; (iii) model 3, model 2 plus aspartate aminotransferase, total cholesterol, triacylglycerol, creatinine, albumin, and systolic blood pressure.
1 secondary outcome
Mediation analysis of smoking relapse on incident T2DM
Time frame: a 7-year cohort study
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 22 Sep 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.
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 Type 2 Diabetes, 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 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: finished, as of the sponsor's last update on 22 Sep 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 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?
Weight Change after smoking cessation on incident T2DM in NAFLD individuals (time frame: a 7-year cohort study). 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 22 Sep 2022.