Skip to main content
OpenTrials
Completed

NCT Number: NCT03847116

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nonalcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Light-to-moderate Alcohol Consumption Liver Diseases Non-alcoholic Fatty Liver Disease Type2 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ningbo first hospital

Ningbo, Zhejiang, 315010, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. LMAC and incident risk of T2DM

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2019
Registry last updated
Jul 5, 2019

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.

Related clinical trials

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