OverweightIRM StéatoseNCT02085876
Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy
An observational study of Overweight and Type 2 Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overweight, Type 2 Diabetes, Obesity
- What is being tested?
- 2 additional MRI sequences and An additional blood sample
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Feb 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Overweight patients or patients with type 2 diabetes or obese patients (who present a liver anomaly and should undergo bariatric surgery)
Who may be able to join
- Patients who have been informed about the research
- Patients with national health insurance cover
- Patients who are overweight (BMI > 25) or have type 2 diabetes suggesting a disturbance of hepatic enzymes (ASAT < 8 times normal values and ALAT > twice normal values) after a complete hepatopathy assessment
- Obese patients with a hepatic anomaly (steatosis) revealed by imaging or biological assessment (ASAT < 8 times normal values and ALAT > twice normal values) who are eligible for bariatric surgery and a preoperative liver MRI examination.
Who cannot join
- Non-corrected coagulation disorder.
- Patients aged over 80 years
- Patients aged less than 18 years
- Patients without legal protection
- Patients with a contra-indication for MRI (Pacemaker, intraocular metallic foreign body, weight>150kg)
- Patients without national health insurance cover
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de DIJON
Dijon, 21079
Samia HAMZA, 3 80 29 37 50 ext. +33, samia.hamza@chu-dijon.fr
About this study
This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy.
To achieve this:
- The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho T2*. The other data will be extracted from usual sequences.
- Part of the histological samples will be used for the weighted levels of fat and iron, and for the lipidomic study.
- Usual blood samples will be completed by samples for the serum library
- Conditions
- Overweight, Type 2 Diabetes, Obesity
- Being tested
- 2 additional MRI sequences, An additional blood sample
- Keywords
- patients, present, undergo bariatric surgery
- Medical subject headings
- Overweight, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 additional MRI sequencesOther
An additional blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring a liver biopsy | Not described Receives: Other: 2 additional MRI sequences; Other: An additional blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine a correlation coefficient > 0.80, alpha 0.05 and beta 0.20 between the MRI markers relevant.
Measured: Baselines
Secondary outcomes (1)
To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis.
Measured: Baselines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Primary completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085876
- Sponsor's protocol ID
- HAMZA APJ 2013
- Acronym
- IRM Stéatose
- Status last verified
- Jul 2013
- First submitted
- 5 Mar 2014
- Last updated
- 13 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy
- ClinicalTrials.gov ID
- NCT02085876
- Acronym / sponsor ID
- IRM Stéatose / HAMZA APJ 2013
- Conditions
- Overweight, Type 2 Diabetes, Obesity
- Keywords
- patients, present, undergo bariatric surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Primary completion
- Feb 2016 (estimated)
- First posted
- 13 Mar 2014 (estimated)
- 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.
This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy.
To achieve this:
- The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho T2*. The other data will be extracted from usual sequences.
- Part of the histological samples will be used for the weighted levels of fat and iron, and for the lipidomic study.
- Usual blood samples will be completed by samples for the serum library
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring a liver biopsy | – | Other: 2 additional MRI sequences, Other: An additional blood sample |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Overweight patients or patients with type 2 diabetes or obese patients (who present a liver anomaly and should undergo bariatric surgery)
Key inclusion criteria (4 listed)
- Patients who have been informed about the research
- Patients with national health insurance cover
- Patients who are overweight (BMI > 25) or have type 2 diabetes suggesting a disturbance of hepatic enzymes (ASAT < 8 times normal values and ALAT > twice normal values) after a complete hepatopathy assessment
- Obese patients with a hepatic anomaly (steatosis) revealed by imaging or biological assessment (ASAT < 8 times normal values and ALAT > twice normal values) who are eligible for bariatric surgery and a preoperative liver MRI examination.
Key exclusion criteria (6 listed)
- Non-corrected coagulation disorder.
- Patients aged over 80 years
- Patients aged less than 18 years
- Patients without legal protection
- Patients with a contra-indication for MRI (Pacemaker, intraocular metallic foreign body, weight>150kg)
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 |
|---|---|---|
| 2 additional MRI sequences | Other | Patients requiring a liver biopsy |
| An additional blood sample | Other | Patients requiring a liver biopsy |
Primary outcome
To determine a correlation coefficient > 0.80, alpha 0.05 and beta 0.20 between the MRI markers relevant.
Time frame: Baselines
1 secondary outcome
To determine the correlation between the unsaturated fat measurements and MRI Lipidomics Spectro analysis.
Time frame: Baselines
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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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.
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 Overweight and Type 2 Diabetes, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 6 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 13 Mar 2014. 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?
Contact Samia HAMZA (3 80 29 37 50 ext. +33, samia.hamza@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine a correlation coefficient > 0.80, alpha 0.05 and beta 0.20 between the MRI markers relevant. (time frame: Baselines). 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 13 Mar 2014.