Status:
UNKNOWN
Liver Fat and Glucagon Resistance
Lead Sponsor:
Imperial College London
Conditions:
Steatosis of Liver
Eligibility:
All Genders
18+ years
Brief Summary
One in four adults worldwide have too much fat stored in the liver which is known as metabolic associated steatotic liver disease (MASLD). This was previously known as non- alcoholic fatty liver disea...
Detailed Description
This is a feasibility cohort-control experimental medicine study. Participants will attend for one study visit lasting 4-5 hours. The study will involve a maximum of 10 healthy volunteers and 10 patie...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA (all patients)
- Male or female
- Able to give full informed consent
- 18 years old or more (children have different metabolism)
- INCLUSION CRITERIA (healthy volunteers) • Normal FIB4 (\<1.3; this indicates no evidence of liver fibrosis)
- INCLUSION CRITERIA (patients with MASLD)
- • Biopsy-proven or clinically diagnosed MASLD (\>5% steatosis)
- EXCLUSION CRITERIA (all patients)
- Current or history of any medical condition that could interfere with the study or potentially cause harm to the participant
- Pregnant or breastfeeding (affects metabolism)
- Recent weight loss or gain (\>10% in previous 3 months)
- History of hypersensitivity to any of the infusates listed in the study design
- Diabetes or pre-diabetes (HbA1C \>42mmol/mol)
- Consumption of over 14 units of alcohol per week
- EXCLUSION CRITERIA (healthy volunteers)
- Evidence of metabolic syndrome
- Previous or current clinical or biochemical evidence of liver disease
- EXCLUSION CRITERIA (patients with MASLD)
- Evidence of liver cirrhosis
- Non-metabolic associated causes of liver disease (e.g. viral hepatitis)
Exclusion
Key Trial Info
Start Date :
March 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06154096
Start Date
March 1 2024
End Date
September 1 2024
Last Update
December 1 2023
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