Non-alcoholic Steato-hepatitisSTEATOGWADNCT06738810
: Identification of Non-alcoholic Steato-hepatitis Cases in a Sample of Type 2 Diabetes Patients, with a Disruption of the Liver Function Tests, At the Pointe-à-Pitre University Hospital
A study testing Fibrotest-actitest/NASHtest in people with Non-alcoholic Steato-hepatitis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
Non-alcoholic steatohepatitis (NASH) develops on insulin resistance, especially in patients with carbohydrate tolerance. NASH may progress to more extensive fibrosis, including cirrhosis, but also to HCC with or without cirrhosis in 10 to 20% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Steato-hepatitis
- What is being tested?
- Fibrotest-actitest/NASHtest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 21 Jun 2018to 1 Feb 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus patient with impaired hepatic function (transaminases and / or PAL and / or gamma-GT> Norm)
- Age ≥18 years
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
- Affiliate or beneficiary of a social security scheme.
Who cannot join
- Pregnancy or breast-feeding
- No diabetes or type 1 diabetes
- Chronic hepatopathy of other origin: viral B, C, alcohol, hemochromatosis, α1-antitrypsin deficiency, Wilson's disease, autoimmune hepatitis
Trial locations and contacts
1 site in 1 country.
Guadeloupe1 site
CHU de la Guadeloupe
Pointe-à-Pitre, Pointe-à-Pitre, 97159
About this study
Official title: Identification of Non-alcoholic Steato-hepatitis Cases in a Sample of Type 2 Diabetes Patients, with a Disruption of the Liver Function Tests, At the Pointe-à-Pitre University Hospital
Non-alcoholic steatohepatitis (NASH) develops on insulin resistance, especially in patients with carbohydrate tolerance. NASH may progress to more extensive fibrosis, including cirrhosis, but also to HCC with or without cirrhosis in 10 to 20% of cases. The main objective of our research is to identify the prevalence of NASH in a sample of 100 patients with type 2 diabetes mellitus (T2DM), consulting in the PAP hospital and having a liver function disorder
Read the detailed description
In Guadeloupe, the prevalence of T2DM is estimated to be 20%, among the highest in the French departements. NASH is probably present in our patients with T2DM but we do not know its prevalence. There is no data on the development of NASH in the Afro-Caribbean population, but in the United States, it has been observed that NASH was less prevalent among African-Americans compared to Caucasian and Hispanic Americans, and this could be explained by differences genetics in fat metabolism. In view of the emergence of NASH worldwide as a cause of chronic liver disease, it is necessary to carry out a pilot study to determine the presence or absence of NASH in T2DM patients in Guadeloupe. This will necessitate a systematic evaluation of liver function, usually performed during the T2DM assessment but not necessarily followed by specialized advice to confirm or invalidate the diagnosis of NASH. For each patient, an abnormality of liver function will be assessed by usual serum tests (transaminases, GGT, PAL). Prescription for a fibrotest / actitest + NASHtest and the NAFLD fibrosis score, will be perfomred as well as ultrasound and blood tests to eliminate other causes of liver disease (viral B or C, alcoholic, autoimmune, hemochromatosis) will also be performed.
- Conditions
- Non-alcoholic Steato-hepatitis
- Being tested
- Fibrotest-actitest/NASHtest
- Keywords
- NASH,, type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrotest-actitest/NASHtestDiagnostic test
Also called NAFLD fibrosis score
A blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest and to calculate the NAFLD fibrosis score
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetes with a hepatic check-up patients | Other | For the study, a blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest. Receives: Diagnostic Test: Fibrotest-actitest/NASHtest |
What is being measured
The primary outcome is the main question the study is designed to answer.
fibrotest-Actitest
Fibrotest-actitest uses the biological analysis of alpha 2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, gGT, ALAT, ASAT, fasting blood glucose, cholesterol, triglycerides. A fibrotest score >0.48 is suggestive of advanced liver fibrosis.
Measured: 24 hours
NASH test
NASHtest uses the biological analysis of alpha 2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, gGT, ALAT, ASAT, fasting blood glucose, cholesterol, triglycerides. NASHtest interpretation:
NashTest 2 score Grade Interpretation
0.00-0.25* N0 No NASH
0.25-0.50* N1 Mild NASH
0.50-0.75* N2 Moderate NASH
0.75-1.00* N3 Severe NASH
Measured: 24 hours
NAFDL fibrosis score
Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score estimates amount of scarring in the liver based on age and body mass index of the patient, and several laboratory tests as ASAT, ALAT, platelet count and albumin. NAFLD fibrosis score can be interpretate as below:
- less than -1.455: low probability of fibrosis
- from -1.445 to 0.676 : intermediate score
- more than 0.676: high probability of fibrosis
Measured: 24 hours
Secondary outcomes (10)
: hepatic ultrasound,
Patients will be assessed by liver ultrasound which is a non invasive test that produces images of liver and its blood vessels. It's a valuable diagnostic tool for assessing liver anatomy, size and pathology as cirrhosis or liver steatosis.
Measured: 24 hours
Standard liver test
Blood analysis for liver function assessment (ASAT, ALAT, gGT, PAL)
Measured: 24 hours
Lipid balance
Blood analysis for lipid metabolism assessment (total cholesterol, HDL cholesterol, triglycerides), which constitutes an important risk factor for cardiovascular disease
Measured: 24 hours
Lipid balance
HDL
Measured: 24 hours
Lipid balance
triglyceride
Measured: 24 hours
Assessment to eliminate other causes of chronic disease
HBV and HCV serologies for viral hepatitis
Measured: 24 hours
Assessment to eliminate other causes of chronic disease
auto-immune antibodies for auto-immune hepatitis
Measured: 24 hours
Assessment to eliminate other causes of chronic disease
ferritinemia and saturation coefficient of transferin for hemochromatosis
Measured: 24 hours
Assessment to eliminate other causes of chronic disease
carboxy deficient transferin for alcoholism
Measured: 24 hours
Platelets
Platelet
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start21 Jun 2018
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Steato-hepatitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There will be a single group. Indeed, all type 2 diabetes with or without a hepatic check-up will be included in the study.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738810
- Sponsor's protocol ID
- PAP_RI2_2017/06
- Other IDs
- 2017-A01101-52
- Acronym
- STEATOGWAD
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any plan has been do
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Non-alcoholic Steato-hepatitis Cases in a Sample of Type 2 Diabetes Patients, with a Disruption of the Liver Function Tests, At the Pointe-à-Pitre University Hospital
- ClinicalTrials.gov ID
- NCT06738810
- Acronym / sponsor ID
- STEATOGWAD / PAP_RI2_2017/06
- Conditions
- Non-alcoholic Steato-hepatitis
- Keywords
- NASH,, type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Dec 2024 (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 steatohepatitis (NASH) develops on insulin resistance, especially in patients with carbohydrate tolerance. NASH may progress to more extensive fibrosis, including cirrhosis, but also to HCC with or without cirrhosis in 10 to 20% of cases. The main objective of our research is to identify the prevalence of NASH in a sample of 100 patients with type 2 diabetes mellitus (T2DM), consulting in the PAP hospital and having a liver function disorder
Detailed description
In Guadeloupe, the prevalence of T2DM is estimated to be 20%, among the highest in the French departements. NASH is probably present in our patients with T2DM but we do not know its prevalence. There is no data on the development of NASH in the Afro-Caribbean population, but in the United States, it has been observed that NASH was less prevalent among African-Americans compared to Caucasian and Hispanic Americans, and this could be explained by differences genetics in fat metabolism. In view of the emergence of NASH worldwide as a cause of chronic liver disease, it is necessary to carry out a pilot study to determine the presence or absence of NASH in T2DM patients in Guadeloupe. This will necessitate a systematic evaluation of liver function, usually performed during the T2DM assessment but not necessarily followed by specialized advice to confirm or invalidate the diagnosis of NASH. For each patient, an abnormality of liver function will be assessed by usual serum tests (transaminases, GGT, PAL). Prescription for a fibrotest / actitest + NASHtest and the NAFLD fibrosis score, will be perfomred as well as ultrasound and blood tests to eliminate other causes of liver disease (viral B or C, alcoholic, autoimmune, hemochromatosis) will also be performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There will be a single group. Indeed, all type 2 diabetes with or without a hepatic check-up will be included in the study.
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes with a hepatic check-up patients | Other | Diagnostic Test: Fibrotest-actitest/NASHtestFor the study, a blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus patient with impaired hepatic function (transaminases and / or PAL and / or gamma-GT> Norm)
- Age ≥18 years
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
- Affiliate or beneficiary of a social security scheme.
Key exclusion criteria (3 listed)
- Pregnancy or breast-feeding
- No diabetes or type 1 diabetes
- Chronic hepatopathy of other origin: viral B, C, alcohol, hemochromatosis, α1-antitrypsin deficiency, Wilson's disease, autoimmune hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrotest-actitest/NASHtestAlso: NAFLD fibrosis scoreA blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest and to calculate the NAFLD fibrosis score | Diagnostic test | type 2 diabetes with a hepatic check-up patients |
Primary outcome
fibrotest-Actitest
Time frame: 24 hours
Fibrotest-actitest uses the biological analysis of alpha 2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, gGT, ALAT, ASAT, fasting blood glucose, cholesterol, triglycerides. A fibrotest score >0.48 is suggestive of advanced liver fibrosis.
NASH test
Time frame: 24 hours
NASHtest uses the biological analysis of alpha 2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, gGT, ALAT, ASAT, fasting blood glucose, cholesterol, triglycerides. NASHtest interpretation: NashTest 2 score Grade Interpretation 0.00-0.25* N0 No NASH 0.25-0.50* N1 Mild NASH 0.50-0.75* N2 Moderate NASH 0.75-1.00* N3 Severe NASH
NAFDL fibrosis score
Time frame: 24 hours
Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score estimates amount of scarring in the liver based on age and body mass index of the patient, and several laboratory tests as ASAT, ALAT, platelet count and albumin. NAFLD fibrosis score can be interpretate as below: * less than -1.455: low probability of fibrosis * from -1.445 to 0.676 : intermediate score * more than 0.676: high probability of fibrosis
10 secondary outcomes
: hepatic ultrasound,
Time frame: 24 hours
Standard liver test
Time frame: 24 hours
Lipid balance
Time frame: 24 hours
Lipid balance
Time frame: 24 hours
Lipid balance
Time frame: 24 hours
Assessment to eliminate other causes of chronic disease
Time frame: 24 hours
Assessment to eliminate other causes of chronic disease
Time frame: 24 hours
Assessment to eliminate other causes of chronic disease
Time frame: 24 hours
Assessment to eliminate other causes of chronic disease
Time frame: 24 hours
Platelets
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No. Any plan has been do
Related trials for Non-alcoholic Steato-hepatitis
Recruiting
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Active, not recruiting
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Type 2 Diabetes Mellitus, Obesity
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Non-invasive Tests for Non-alcoholic Steato-hepatitis
NASH With Fibrosis, Diabete Type 2
Not yet recruiting
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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?
A study testing Fibrotest-actitest/NASHtest in people with Non-alcoholic Steato-hepatitis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 18 Dec 2024. 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 Guadeloupe. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
fibrotest-Actitest (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 18 Dec 2024.