No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Observational
Participants needed
10,000 (estimated)
Sponsor
Julius Clinical · Industry
Who this trial is looking for
This trial is looking for people who have type 2 diabetes, obesity, or high blood pressure. Participants will help improve the care process for patients at risk of liver disease in primary care settings across Europe.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with type 2 diabetes.
I have been diagnosed with obesity.
I have been diagnosed with metabolic syndrome.
I have been diagnosed with arterial hypertension.
I am currently being treated for type 2 diabetes.
I am currently being treated for obesity.
I am currently being treated for metabolic syndrome.
I am currently being treated for arterial hypertension.
You may not be able to join if
I have hepatitis B, C, or HIV.
I have a liver condition like hemochromatosis or Wilson's disease.
I drink more than 3 units of alcohol a day.
I have a significant health condition that could affect my safety.
I am pregnant or breastfeeding.
I had bariatric surgery in the last 12 months.
I cannot understand the study details or give consent.
I am connected to the research team as an employee or family member.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to…
GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to identify patients with MASLD and its progressive form metabolic dysfunction-associated steatohepatitis (MASH) in primary care centres and clinics in 10 European countries.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Newly diagnosed subjects should fulfil criteria for diagnosis of type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, following the study definitions.
* Subjects that are currently being treated for type 2 diabetes mellitus or metabolic syndrome …
Inclusion Criteria:
* Newly diagnosed subjects should fulfil criteria for diagnosis of type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, following the study definitions.
* Subjects that are currently being treated for type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, should have had a prior diagnosis based on study definitions.
Study definitions:
Type 2 diabetes mellitus
* At least 2 times a fasting glucose \> 7,0 mmol/L
* Or elevated non-fasting glucose \>11,1 mmol/L 2 hrs after OGTT
* Or HbA1c ≥48 mmol/mol (≥6.5%)
* Or being actively treated for previously diagnosed type 2 diabetes by a health care provider
Obesity
* Body mass index (BMI) \> 30
* Or waist circumferences Caucasian: male ≥ 94 cm, female ≥ 80 cm South-Asian/Chinese: male ≥90 cm, female ≥80 cm Japanese: male ≥85 cm, female ≥90 cm
Arterial hypertension
* Systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg
* Or being actively treated for previously diagnosed arterial hypertension by a health care provider
Metabolic syndrome
\- Central obesity defined as waist circumference (see above), if BMI is \>30 kg/m2, central obesity can be assumed and waist circumference does not need to be measured
AND any two of the following:
* Raised triglycerides: ≥ 150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality
* Reduced HDL cholesterol: \< 40 mg/dL (1.03 mmol/L) in males, \< 50 mg/dL (1.29 mmol/L) in females, or specific treatment for this lipid abnormality
* Raised blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension
* Raised fasting plasma glucose (FPG): FGP ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (if above \>5.6 mmol/L or 100 mg/dL, an oral glucose tolerance test is strongly recommended, but is not necessary to define presence of the syndrome)
Exclusion Criteria:
* The patient is known with hepatitis B, C or HIV or any other liver condition (like hemochromatosis, sarcoidosis, Wilson's disease etc);
* The patient is known with any other condition that may lead to liver fibrosis or cirrhosis;
* The patient engages in (excessive) alcohol use: \> 3 units/day in males \[30 grams/day\] and \> 2 units/day in females \[20 grams/day\];
* The patient has a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the Investigator, may compromise the patient's safety or ability to be included in this study;
* The patient is an employee or contractor of the facility that is conducting the study or is a family member of the Investigator, sub-Investigator, or any Sponsor personnel;
* The patient is not able to understand the details of the protocol and/or is not able to provide written informed consent;
* The patient is pregnant or breastfeeding.
* The patient underwent bariatric surgery in the last 12 months.
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