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Status unknownNCT04493814Updated Jul 30, 2020

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

An observational study in NAFLD and Type 2 Diabetes, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-30.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
86
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • NAFLD
  • Type 2 Diabetes

Keywords

  • NAFLD
  • NASH
  • Insulin resistance
  • Type 2 diabetes
  • Visceral Adipose Tissue
  • DXA
  • Fibroscan
  • Vibration-Controlled Transient Elastography
  • Liver cirrhosis
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 86 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
86 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: July to September 2020

Secondary outcomes

  1. 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

    Time frame: July to September 2020

  2. 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.

    Time frame: July to September 2020

  3. 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.

    Time frame: July to September 2020

  4. 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.

    Time frame: July to September 2020

  5. 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.

    Time frame: July to September 2020

  6. Determine the diagnostic performances of different biologic markers for histologic fibrosis diagnosis.

    Histologic fibrosis determined on hepatic biopsy.

    Time frame: July to September 2020

  7. Build an algorithm with Visceral adipose Tissue mesured and biological markers to predict fibrosis.

    Prediction algorithm for hepatic fibrosis based on different markers

    Time frame: July to September 2020

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Study locations

1 site
  • GUERCI Bruno
    Nancy, 54500, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04493814
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Jul 30, 2020
Start date
Jul 2020 (estimated)
Primary completion
Aug 2020 (estimated)
Completion
Aug 2020 (estimated)
Last update
Jul 30, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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