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

NCT ID: NCT04493814

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-31

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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NAFLD Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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GUERCI Bruno

Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2019PI279

Identifier Type: -

Identifier Source: org_study_id

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