Weight Gain After Smoking Cessation and NAFLD

Completed

• Conditions: Nonalcoholic Fatty Liver Disease; Type 2 Diabetes

• Registration Number: NCT05550688
• Lead Sponsor: Ningbo No. 1 Hospital

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2014-12-31
• Study Completion: 2022-08-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-20
• Last Update Submitted: 2022-09-20
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12941

Inclusion Criteria

(i) age>=18 years.

Exclusion Criteria

(i) 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight Change after smoking cessation on incident T2DM in NAFLD individuals	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	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.

Secondary Outcome Measures

Name	Time	Method
Mediation analysis of smoking relapse on incident T2DM	a 7-year cohort study	The investigators conducted a mediation analysis to assess whether the association between smoking status and NAFLD was mediated by smoking relapse.

Trial Locations

Locations (1)

Ningbo first hospital; 🇨🇳 Ningbo, Zhejiang, China