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

Type2 Diabetes Mellitus Clinical Trial

Official title:

Association of Light-to-moderate Alcohol Consumption With Risk of Type 2 Diabetes Mellitus in Individuals With Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847116
• Other study ID #: LHNAFLD 2018-V1.0
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: February 10, 2019

Study information

• Verified date: July 2019
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14014
• Est. completion date: February 10, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Light-to-moderate Alcohol Consumption
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease
• Type2 Diabetes Mellitus

Locations

Country	Name	City	State
China	Ningbo first hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Light-to-moderate alcohol consumption (LMAC) and risk of prevalent type 2 diabetes mellitus (T2DM)	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.	cross-sectional analyses in 2009
Secondary	LMAC and incident risk of T2DM	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.	9-year cohort observation