Status:
RECRUITING
Effect of VLCD on the Reduction of Liver Steatosis and Fibrosis in Subjects With Obesity and NAFLD
Lead Sponsor:
University of Iowa
Conditions:
NAFLD
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is a common complication of obesity which can progress to deadly complications like end-stage liver disease and hepatocellular carcinoma. In the wake of the o...
Detailed Description
Study design: The investigators plan to perform a controlled, non-randomized, open-label, pilot clinical trial to evaluate the effect of an 8-week VLCD intervention on NAFLD. The main variable of this...
Eligibility Criteria
Inclusion
- Inclusion and Exclusion Criteria
- The inclusion criteria for participation are as follows:
- Male and female subjects with age ≥ 18 years old and \< 70 years old.
- BMI ≥ 30 kg/m2 and ≤ 50 kg/m2
- Negative tests for viral hepatitis C (hepatitis C antibody) and autoimmune hepatitis (anti-smooth muscle antibody)
- Evidence of liver steatosis on an image method such as ultrasound, CT scan or MRI, or subjects with elastography score F1 and above and/or S1 and above can be included
- The exclusion criteria are as follows:
- Type 1 diabetes mellitus
- Subjects with type 2 diabetes mellitus who use insulin
- Heart failure
- Myocardial infarction within last 6 months
- Unstable angina
- Chronic kidney disease with eGFR ≤ 30 mL/min/1.73 m²
- Chronic obstructive pulmonary disease requiring O2 supplementation
- Coexisting liver disease or end-stage liver disease
- Severe or uncontrolled mental health disease, including eating disorders
- Gout
- History of uric acid nephrolithiasis
- Porphyria
- Conception attempts, confirmed pregnancy or breast feeding
- Past or active cholecystitis without cholecystectomy
- Uncontrolled hyperthyroidism
- Uncontrolled hypothyroidism with TSH ≥ 10 mcIU/mL
- Excessive alcohol consumption (that is, an AUDIT-C score ≥ 4 for men and ≥ 3 for women)
- Use of warfarin, lithium, chronic use of prednisone (20mg or more daily)
- Subjects with no elastography in the previous 12 months will be excluded from the study
- Subjects with F0 and S0 on elastography will be excluded
Exclusion
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04861571
Start Date
October 1 2023
End Date
December 1 2026
Last Update
January 17 2025
Active Locations (1)
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1
University of Iowa Health Care
Iowa City, Iowa, United States, 52242