Study Visceral Adipose Tissue and Liver Stifness in a Retrospective Cohort of Diabetes Mellitus Patients

Study of Association Between Quantity (and Percentage) of Visceral Adipose Tissue and NAFLD-linked Liver Stifness as Mesured by Fibroscan in a Retrospective Cohort of Diabetes Mellitus Patients

Non Alcoholic Fatty Liver Disease (NAFLD) is an emergent disease worldwide, and soon the leading cause of hepatic transplant in the USA. Among this high number of patients, the current challenge is to detect or even predict patients at risk of inflammation (Non Alcoholic or Steatohepatitis or NASH) and end-stage fibrosis, which are the best predictors of liver-related mortality.

Visceral obesity is intimately associated with metabolic disease and adverse health outcomes, such as diabetes, and NAFLD. It has been demonstrated that visceral adipose tissue-linked inflammation was a risk factor of stroke, myocardial infarction, and others metabolic-related complications.

The aim of this study was to evaluate the association of the quantity and percentage of Visceral Adipose Tissue by Dual X-Ray Absorptiometry and liver stiffness by Fibroscan in patients with type 2 diabetes, and other predictors of fibrosis such as FIB-4 and Fibrotest. We retrospectively collected the data of all the diabetic patients who had undergone a DEXA and a Fibroscan between January 1st, 2014 and Decembre 31th, 2019, in the Universitary Hospital of Nancy, France.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes; NAFLD

• Study Type: Observational
• Enrollment (Anticipated): 86

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54500
    • GUERCI Bruno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the patients with type 2 diabetes, followed and Universitary Hospital of Nancy, France, who had undergone a DEXA and a VCTE examination during their care path, in less than a year apart, between 2014 and 2019.

Description

Inclusion Criteria:

• Type 2 diabetes mellitus
• Patients who had undergone a VCTE examen at Universitary Hospital of Nancy between January 1st, 2014 and December 31th, 2019
• - Patients who had undergone a DEXA at Universitary Hospital of Nancy with less than one year of difference with VCTE

Exclusion Criteria:

• Viral, ethylic, drug-linked, genetic, self-immune hepatitis, liver cancer or metatasis ; other causes who could interact with fibroscan or biological markers (thrombocytopenia, undernutrition)
• Type 1 diabetes mellitus
• Weight variation (>5% of body weight) between DEXA mesure and Fibroscan mesure
• Fail of VCTE examination
• High alcohol consumption (>30g/day for men and >20g.day for women)
• Pregnant women
• Other causes of secondary hepatic steatosis (drug-linked, parenteral nutrition, rare diseases...)
• Any other pathology that the investigator would consider not compatible with the research
• Patients in any other research protocol three months before inclusion
• Person referred as in the Public Health code (articles L.1121-5, L.1121-7 and L.1121-8) : pregnant or nursing woman, minor adult, major adult under legal protection, adult unable of giving consent
• Person deprived of their liberty by judicial or administrative decision, person under psychiatric care as described in articles L. 3212-1 and L.3213-1.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort; All the patients with type 2 diabetes followed at Universitary Hospital of Nancy who had undergone a DEXA and a Fibroscan between 2014 and 2019.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between quantity of Visceral adipose Tissu and Liver Stiffness	Visceral adipose tissu in grams mesured by DEXA, and Liver stiffness in kiloPascal mesured par Vibration-Controlled Transient Elastography	July to September 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between percentage of Visceral adipose Tissu and Liver Stiffness	Visceral adipose tissu in percentage on total fat mass mesured by DEXA, and Liver stiffness in kiloPascal mesured par Vibration-Controlled Transient Elastography	July to September 2020
Association between quantity of Visceral adipose Tissue and histologic Fibrosis	Visceral adipose tissu in grams mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.	July to September 2020
Association between percentage of Visceral adipose Tissue and histologic Fibrosis	Visceral adipose tissu percentage on total fat mass mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.	July to September 2020
Determine the diagnostic performances of quantity of Visceral adipose Tissue for histologic fibrosis diagnosis.	Visceral adipose tissu in grams mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.	July to September 2020
Determine the diagnostic performances of percentage of Visceral adipose Tissue for histologic fibrosis diagnosis.	Visceral adipose tissu percentage on total fat mass mesured by DEXA, and histologic fibrosis determined on hepatic biopsy.	July to September 2020
Determine the diagnostic performances of different biologic markers for histologic fibrosis diagnosis.	Histologic fibrosis determined on hepatic biopsy.	July to September 2020
Build an algorithm with Visceral adipose Tissue mesured and biological markers to predict fibrosis.	Prediction algorithm for hepatic fibrosis based on different markers	July to September 2020

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Insulin resistance; Type 2 diabetes; NAFLD; NASH; DXA; Liver cirrhosis; Visceral Adipose Tissue; Fibroscan; Vibration-Controlled Transient Elastography
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2019PI279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No