NASH - Nonalcoholic SteatohepatitisCONNECTNCT04653103
NASH in Subjects With Different Classes of Obesity
An observational study of NASH - Nonalcoholic Steatohepatitis and NAFLD, run by Catholic University of the Sacred Heart at 2 sites in Italy.
Trial summary
It is an observational trial on 500 subjects. The purpose of this trial is to assess the prevalence of non-alcoholic steatohepatitis (NASH) in subjects with different classes of obesity. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis, NAFLD, Obesity
- What is being tested?
- Liver biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesItaly
- Study dates
- 20 Nov 2020to 25 Jan 2023
- 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 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with different classes of obesity
Who may be able to join
- Aged between 19 and 69 years
Who cannot join
- Pregnancy
- Active cancer
- End stage renal failure
- End stage liver failure
- Being unable to understand and sign informed consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University of Rome Sapienza
Roma
Catholic University School of Medicine
Rome, 00168
About this study
Official title: Prevalence of NASH in Subjects With Different Classes of Obesity
It is an observational trial on 500 subjects. The purpose of this trial is to assess the prevalence of non-alcoholic steatohepatitis (NASH) in subjects with different classes of obesity.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common cause of chronic liver disease due to an increase in the prevalence of obesity. The development of NASH leads to an increase in morbidity and mortality. Since patients with obesity are at an increased risk of NASH, the aim of this trial is to assess the prevalence of NASH in this class of patients.
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD, Obesity, Obesity, Morbid
- Being tested
- Liver biopsy
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver biopsyProcedure or surgery
Biopsy of the liver to assess for Non-alcoholic steatohepatitis
| Study group | Role | What they receive |
|---|---|---|
| Patients with obesity | Subjects with different classes of obesity Receives: Procedure: Liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of NASH
Prevalence of NASH in a cohort of patients with different classes of obesity
Measured: 6 months
Secondary outcomes (6)
Assessment of lipid profile
Assessment of triglycerides, total cholesterol, LDL and HDL cholesterol
Measured: 6 months
Assessment of glycemic profile
Assessment of fasting glucose
Measured: 6 months
Assessment of glycated hemoglobin
Assessment of glycated hemoglobin
Measured: 6 months
Assessment of liver enzymes
Assessment of AST, ALT, GGT
Measured: 6 months
Assessment of insulin
Assessment of fasting insulin
Measured: 6 months
Assessment of metabolic profile
Assessment of HOMA-IR index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start20 Nov 2020
- Primary completion25 Jan 2021
- Study completion25 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geltrude Mingrone, Catholic University of the Sacred Heart
- Investigators
- Geltrude Mingrone, MD, PhD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653103
- Sponsor's protocol ID
- 20202011
- Acronym
- CONNECT
- Status last verified
- May 2021
- First submitted
- 20 Nov 2020
- Last updated
- 18 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of NASH in Subjects With Different Classes of Obesity
- ClinicalTrials.gov ID
- NCT04653103
- Acronym / sponsor ID
- CONNECT / 20202011
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD, Obesity, Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2023 (estimated)
- First posted
- 4 Dec 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.
It is an observational trial on 500 subjects. The purpose of this trial is to assess the prevalence of non-alcoholic steatohepatitis (NASH) in subjects with different classes of obesity.
Detailed description
Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common cause of chronic liver disease due to an increase in the prevalence of obesity. The development of NASH leads to an increase in morbidity and mortality. Since patients with obesity are at an increased risk of NASH, the aim of this trial is to assess the prevalence of NASH in this class of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with obesity | – | Procedure: Liver biopsySubjects with different classes of obesity |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with different classes of obesity
Key inclusion criteria (1 listed)
- Aged between 19 and 69 years
Key exclusion criteria (5 listed)
- Pregnancy
- Active cancer
- End stage renal failure
- End stage liver failure
- Being unable to understand and sign informed consent
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 |
|---|---|---|
| Liver biopsyBiopsy of the liver to assess for Non-alcoholic steatohepatitis | Procedure or surgery | Patients with obesity |
Primary outcome
Prevalence of NASH
Time frame: 6 months
Prevalence of NASH in a cohort of patients with different classes of obesity
6 secondary outcomes
Assessment of lipid profile
Time frame: 6 months
Assessment of glycemic profile
Time frame: 6 months
Assessment of glycated hemoglobin
Time frame: 6 months
Assessment of liver enzymes
Time frame: 6 months
Assessment of insulin
Time frame: 6 months
Assessment of metabolic profile
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: No
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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.
Geltrude Mingrone, MD, PhD principal investigator
Catholic University of the Sacred Heart
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NASH - Nonalcoholic Steatohepatitis and NAFLD, run by Catholic University of the Sacred Heart at 2 sites in Italy.
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 1 inclusion and 5 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 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Prevalence of NASH (time frame: 6 months). 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 May 2021.