Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements

NCT03060694 | Completed

• 1 other identifier: XH-16-045
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the severity of NAFLD in diabetic patients to that in non-diabetic patients.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• controlled attenuation parameter; liver stiffness measure

  one day

Study Arms (2)

Diabetes group

Patients in this group are recruited from both departments of endocrinology and gastroenterology. The diagnosis of diabetes is confirmed by medical history, using anti-diabetic medicines or laboratory tests.

Other: diabetes

Non-diabetes group

Patients in this group are recruited from department of gastroenterology. The exclusion of diabetes is confirmed by medical history or laboratory tests.

Interventions

diabetes OTHER

1. a history of diabetes and using anti-diabetic medicines. 2. fasting serum glucose level greater than 7.1mmol/L, or glycosylated hemoglobin percentage greater than 6.5%.

Diabetes group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

inpatients in the department of endocrinology in Xinhua Hospital

You may qualify if:

• ≥18 years
• type 2 diabetics

You may not qualify if:

• malignancy;
• severe cardiovascular complications;
• any history of chronic hepatitis (hepatitis B or C virus infection, autoimmune hepatitis, Wilson's disease, hemachromatosis);
• secondary causes of fatty liver ( glucocorticoids, amiodarone, tamoxifen);
• alcohol consuming (20grams per day for male, and 10 grams per day for female);
• any hints of type 1 diabetes ( ketoacidosis, ketonuria, using insulin within 1 year after diagnosis)

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

Shanghai, China

Location

Related Publications (2)

• Kwok R, Choi KC, Wong GL, Zhang Y, Chan HL, Luk AO, Shu SS, Chan AW, Yeung MW, Chan JC, Kong AP, Wong VW. Screening diabetic patients for non-alcoholic fatty liver disease with controlled attenuation parameter and liver stiffness measurements: a prospective cohort study. Gut. 2016 Aug;65(8):1359-68. doi: 10.1136/gutjnl-2015-309265. Epub 2015 Apr 14.

  PMID: 25873639 RESULT

• Karlas T, Petroff D, Sasso M, Fan JG, Mi YQ, de Ledinghen V, Kumar M, Lupsor-Platon M, Han KH, Cardoso AC, Ferraioli G, Chan WK, Wong VW, Myers RP, Chayama K, Friedrich-Rust M, Beaugrand M, Shen F, Hiriart JB, Sarin SK, Badea R, Jung KS, Marcellin P, Filice C, Mahadeva S, Wong GL, Crotty P, Masaki K, Bojunga J, Bedossa P, Keim V, Wiegand J. Individual patient data meta-analysis of controlled attenuation parameter (CAP) technology for assessing steatosis. J Hepatol. 2017 May;66(5):1022-1030. doi: 10.1016/j.jhep.2016.12.022. Epub 2016 Dec 28.

  PMID: 28039099 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Zhengjie Xu, MD

  Xinhua Hospital, Shanghai Jiaotong Univerisity School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 23, 2017
• Study Start: September 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 11, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)