Weight Gain After Smoking Cessation and NAFLD

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.

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Key information

Conditions

Nonalcoholic Fatty Liver Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ningbo first hospital

Ningbo, Zhejiang, 315000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Mediation analysis of smoking relapse on incident T2DM

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

The Effect of Weight Gain After Smoking Cessation Increased the Risk of Type 2 Diabetes in Individuals With Nonalcoholic Fatty Liver Disease

Important dates

Study start: 2007
Primary completion: 2014
Study completion: 2022
First posted: Sep 22, 2022
Registry last updated: Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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