NAFLDNCT04493814
Study Visceral Adipose Tissue and Liver Stifness in a Retrospective Cohort of Diabetes Mellitus Patients
An observational study of NAFLD and Type 2 Diabetes, run by Central Hospital, Nancy, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Type 2 Diabetes
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2020to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- NAFLD, Type 2 Diabetes
- Keywords
- NAFLD, NASH, Insulin resistance, Type 2 diabetes, Visceral Adipose Tissue, DXA, Fibroscan, Vibration-Controlled Transient Elastography, Liver cirrhosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Insulin Resistance, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: July to September 2020
Secondary outcomes (7)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: July to September 2020
Determine the diagnostic performances of different biologic markers for histologic fibrosis diagnosis.
Histologic fibrosis determined on hepatic biopsy.
Measured: 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
Measured: July to September 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study startJul 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493814
- Sponsor's protocol ID
- 2019PI279
- Status last verified
- Jun 2020
- First submitted
- 28 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04493814
- Acronym / sponsor ID
- 2019PI279
- Conditions
- NAFLD, Type 2 Diabetes
- Keywords
- NAFLD, NASH, Insulin resistance, Type 2 diabetes, Visceral Adipose Tissue, DXA, Fibroscan, Vibration-Controlled Transient Elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between quantity of Visceral adipose Tissu and Liver Stiffness
Time frame: July to September 2020
Visceral adipose tissu in grams mesured by DEXA, and Liver stiffness in kiloPascal mesured par Vibration-Controlled Transient Elastography
7 secondary outcomes
Association between percentage of Visceral adipose Tissu and Liver Stiffness
Time frame: July to September 2020
Association between quantity of Visceral adipose Tissue and histologic Fibrosis
Time frame: July to September 2020
Association between percentage of Visceral adipose Tissue and histologic Fibrosis
Time frame: July to September 2020
Determine the diagnostic performances of quantity of Visceral adipose Tissue for histologic fibrosis diagnosis.
Time frame: July to September 2020
Determine the diagnostic performances of percentage of Visceral adipose Tissue for histologic fibrosis diagnosis.
Time frame: July to September 2020
Determine the diagnostic performances of different biologic markers for histologic fibrosis diagnosis.
Time frame: July to September 2020
Build an algorithm with Visceral adipose Tissue mesured and biological markers to predict fibrosis.
Time frame: July to September 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD and Type 2 Diabetes, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between quantity of Visceral adipose Tissu and Liver Stiffness (time frame: July to September 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.