NCT04059029

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of abnormal liver biochemistry tests in the world. The prevalence rate of NAFLD has been reported to be 30-40% in men and 15-20% in women, up to 70% of people with type 2 diabetes mellitus (Type 2 DM) and even surpassing 74% to 90% of morbidly obese patients with body mass index (BMI) higher than 35 kg/m\^2. The primary aims of this prospective cohort study would evaluate the predictive factors of successful weight reduction, NAFLD and nonalcoholic steatohepatitis (NASH) improvement in a large cohort of morbidly obese patients undergoing bariatric surgery. Secondarily, the diagnostic accuracy of noninvasive serum markers, doppler ultrasonography and transient elastography would be validated. Thirdly, we would conduct gene expression analyses to elucidate biological pathways underlying NAFLD phenotypes in this unique cohort.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 16, 2019

Status Verified

September 1, 2016

Enrollment Period

3.8 years

First QC Date

December 22, 2016

Last Update Submit

August 15, 2019

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Keywords

Nonalcoholic fatty liver diseasemorbidly obeseBariatric surgery

Outcome Measures

Primary Outcomes (1)

  • Change from body mass index (BMI) at 12 months after surgery

    The BMI would be calculated by dividing the body weight (in kilograms) by the square body height (in meters).

    pre-surgery and 12 months after surgery

Secondary Outcomes (3)

  • Change from alanine aminotransferase at 12 months after surgery

    pre-surgery and 12 months after surgery

  • Change from aspartate aminotransferase at 12 months after surgery

    pre-surgery and 12 months after surgery

  • Nonalcoholic steatohepatitis

    1 day of surgery

Study Arms (1)

Morbidly obese patients with NAFLD

Morbidly obese patient with Nonalcoholic fatty liver disease. The starting point for each patient is the day of surgery and the end-point is 1 year after the operation. During bariatric surgery, all patients would undergo a wedge liver biopsy under laparoscopic guidance. The diagnosis of NASH would be made histologically.

Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

During bariatric surgery, all patients would undergo a wedge liver biopsy under laparoscopic guidance.

Morbidly obese patients with NAFLD

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Morbidly obese patient undergoing bariatric surgery

You may qualify if:

  • Adult male and female Morbidly obese patients age 20-65 years with BMI over 37.5 kg/m\^2, or BMI over 32.5 kg/m\^2 with comorbidity other than diabetes (hypertension, NASH, dyslipidemia, obstructive sleep apnea, osteoarthritis joint…etc.) or BMI over 27.5 kg/m\^2 with poor control diabetes undergoing bariatric surgery

You may not qualify if:

  • The presence of end organ damage
  • Previous bariatric surgery
  • Women who are pregnant or nursing
  • Prolonged exposure to known hepatotoxins such as alcohol or drugs
  • Concurrent hepatitis B virus, hepatitis C virus, hepatitis D virus, or human immunodeficiency virus infection
  • Concurrent autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis
  • Wilson disease or hemochromatosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ; American Gastroenterological Association; American Association for the Study of Liver Diseases; American College of Gastroenterologyh. The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Gastroenterological Association, American Association for the Study of Liver Diseases, and American College of Gastroenterology. Gastroenterology. 2012 Jun;142(7):1592-609. doi: 10.1053/j.gastro.2012.04.001. Epub 2012 May 15. No abstract available.

    PMID: 22656328BACKGROUND

  • Rinella ME. Nonalcoholic fatty liver disease: a systematic review. JAMA. 2015 Jun 9;313(22):2263-73. doi: 10.1001/jama.2015.5370.

    PMID: 26057287BACKGROUND

  • Morita S, Neto Dde S, Morita FH, Morita NK, Lobo SM. Prevalence of Non-alcoholic Fatty Liver Disease and Steatohepatitis Risk Factors in Patients Undergoing Bariatric Surgery. Obes Surg. 2015 Dec;25(12):2335-43. doi: 10.1007/s11695-015-1696-5.

    PMID: 25920616BACKGROUND

  • Puzziferri N, Roshek TB 3rd, Mayo HG, Gallagher R, Belle SH, Livingston EH. Long-term follow-up after bariatric surgery: a systematic review. JAMA. 2014 Sep 3;312(9):934-42. doi: 10.1001/jama.2014.10706.

    PMID: 25182102BACKGROUND

  • Arterburn D, Powers JD, Toh S, Polsky S, Butler MG, Portz JD, Donahoo WT, Herrinton L, Williams RJ, Vijayadeva V, Fisher D, Bayliss EA. Comparative effectiveness of laparoscopic adjustable gastric banding vs laparoscopic gastric bypass. JAMA Surg. 2014 Dec;149(12):1279-87. doi: 10.1001/jamasurg.2014.1674.

    PMID: 25353723BACKGROUND

  • Lee WJ, Almulaifi A, Chong K, Chen SC, Tsou JJ, Ser KH, Lee YC, Chen JC. The Effect and Predictive Score of Gastric Bypass and Sleeve Gastrectomy on Type 2 Diabetes Mellitus Patients with BMI < 30 kg/m(2). Obes Surg. 2015 Oct;25(10):1772-8. doi: 10.1007/s11695-015-1603-0.

    PMID: 25676157BACKGROUND

  • Kao WY, Lin YF, Chang IW, Chen CL, Tang JH, Chang CC, Chang YJ, Wang W. Interleukin-2 receptor alpha as a biomarker for nonalcoholic fatty liver disease diagnosis. J Chin Med Assoc. 2021 Mar 1;84(3):261-266. doi: 10.1097/JCMA.0000000000000469.

    PMID: 33306598DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

During bariatric surgery, all patients would undergo a wedge liver biopsy under laparoscopic guidance. The diagnosis of NASH and liver fibrosis would be made histologically. The levels of total cholesterol, low-density lipoprotein, triglyceride, albumin, insulin, glucose, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, C-peptide, iron, calcium, complete blood cell counts would be assessed before and 12 months after bariatric surgery.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Weu Wang, M.D.&PhD

    Comprehensive weight management center, Taipei Medical University hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2016

First Posted

August 16, 2019

Study Start

October 1, 2016

Primary Completion

July 1, 2020

Study Completion

July 1, 2021

Last Updated

August 16, 2019

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share