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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04493814
• Other study ID #: 2019PI279
• Status: Not yet recruiting
• Start date: July 2020
• Est. completion date: August 2020

Study information

• Verified date: June 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• NAFLD
• Type 2 Diabetes

Locations

Country	Name	City	State
France	GUERCI Bruno	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Determine the diagnostic performances of different biologic markers for histologic fibrosis diagnosis.	Histologic fibrosis determined on hepatic biopsy.	July to September 2020
Secondary	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