Alcohol Consumption and Type 2 Diabetes Mellitus Risk in Nonalcoholic Fatty Liver Disease

Completed

• Conditions: Nonalcoholic Fatty Liver Disease; Light-to-moderate Alcohol Consumption; Type2 Diabetes Mellitus

• Registration Number: NCT03847116
• Lead Sponsor: Ningbo No. 1 Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-02-10
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14014

Inclusion Criteria

1. aged 18 years or above
2. undergoing annual health examinations in 2009 in Zhenhai Lianhua Hospital, Ningbo, China.
3. informed about the study

Exclusion Criteria

1. female participants;
2. missing data on ultrasound, alcohol consumption, and T2DM status;
3. alcohol consumption > 210 g per week, and binge drinkers;
4. with evidence of other liver diseases including viral hepatitis, autoimmune hepatitis, and drug-induced liver disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Light-to-moderate alcohol consumption (LMAC) and risk of prevalent type 2 diabetes mellitus (T2DM)	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.

Secondary Outcome Measures

Name	Time	Method
LMAC and incident risk of T2DM	9-year cohort observation	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.

Trial Locations

Locations (1)

Ningbo first hospital; 🇨🇳 Ningbo, Zhejiang, China