Weight Gain After Smoking Cessation and NAFLD

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Nonalcoholic Fatty Liver Disease

• Study Type: Observational
• Enrollment (Actual): 12941

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • Ningbo First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators enrolled participants who took annual health examinations at Zhenhai Lianhua Hospital in 2007.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	a 7-year cohort study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	a 7-year cohort study

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2007
• Primary Completion (ACTUAL): December 31, 2014
• Study Completion (ACTUAL): August 1, 2022

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (ACTUAL): September 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Body Weight Changes; Liver Diseases; Diabetes Mellitus, Type 2; Fatty Liver; Non-alcoholic Fatty Liver Disease; Weight Gain
• Other Study ID Numbers: NAFLD_quitsmoking

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No