A multicenter, randomized, double masked, placebo-controlled, parallel treatment groups phase 2 trial of losartan for pediatric nonalcoholic fatty liver disease (NAFLD).
Children ages 8-17 years weighing between 70 -149 kilograms will be enrolled and treated with losartan (100 mg orally once per day) or matching placebo for 24 weeks. The hypothesis is that losartan will improve serum alanine aminotransferase (ALT) in children with pediatric NAFLD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
83
Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
Matching placebo losartan oral capsule
University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Change in Serum Alanine Aminotransferase (ALT) From Baseline.
Change ALT value in U/L (24 weeks minus baseline). A negative score indicates improvement.
Time frame: Baseline and 24 weeks
Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline
Change from baseline in gamma-glutamyl transpeptidase (GGT), measured in U/L.
Time frame: Baseline and 24 weeks
Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST
Change from baseline in serum aspartate aminotransferase, measured in U/L.
Time frame: Baseline and 24 weeks
Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT
Relative change from baseline in serum ALT, measured in percentage of change.
Time frame: Baseline and 24 weeks
Change in ALT at 12 Weeks Compared to Baseline ALT
Change from baseline in ALT at 12 weeks, measured in U/L.
Time frame: Baseline and 12 weeks
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Compared to Baseline.
Homeostasis Model Assessment of Insulin Resistance Index (HOMA-IR) measures insulin resistance, calculated by fasting insulin (umol/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.
Time frame: Baseline and 24 weeks
Change in Weight at 24 Weeks Compared to Baseline
Change from baseline in weight, measured in kg.
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Northwestern Univ-Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
St. Louis University
St Louis, Missouri, United States
Columbia University
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Time frame: Baseline and 24 weeks
Change in Body Mass Index (BMI) at 24 Weeks Compared to Baseline.
Change from baseline in BMI, measured in kg/m\^2.
Time frame: Baseline and 24 weeks
Change in Waist Circumference at 24 Weeks Compared to Baseline
Change from baseline in waist circumference, measured in centimeters.
Time frame: Baseline and 24 weeks
Change in Waist-to-hip Ratio at 24 Weeks Compared to Baseline
Change from baseline in waist-to-hip ratio, measured as the circumference of the waist in centimeters divided by the circumference of the hips in centimeters.
Time frame: Baseline and 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQOL) Physical Health Score at 24 Weeks Compared to Baseline
Pediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Physical Health Summary Score =Physical Functioning Scale Score. The outcome is 24-week change from baseline in PedsQOL Physical Health Score, where higher values indicate improvement in quality of life.
Time frame: Baseline and 24 weeks
Frequency of Adverse Events Over 24 Weeks
Numbers of adverse events reported over 24 weeks.
Time frame: Baseline and 24 weeks
Change in Total Cholesterol at 24 Weeks Compared to Baseline
Change from baseline in total cholesterol, measured in mg/dL
Time frame: Baseline and 24 weeks
Change in Triglycerides at 24 Weeks Compared to Baseline
Change from baseline in triglycerides, measured in mg/dL
Time frame: Baseline and 24 weeks
Change in HDL Cholesterol at 24 Weeks Compared to Baseline
Change from baseline in HDL cholesterol, measured in mg/dL
Time frame: Baseline and 24 weeks
Change in LDL Cholesterol at 24 Weeks Compared to Baseline
Change from baseline in LDL cholesterol, measured in mg/dL
Time frame: Baseline and 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQOL) Psychosocial Health Score at 24 Weeks Compared to Baseline
Pediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Psychosocial Health Summary Score = Sum of items over the number of items answered in the Emotional, Social, and School Functioning Scales. The outcome is 24-week change from baseline in PedsQOL Psychosocial Health Score, where higher values indicate improvement in quality of life.
Time frame: Baseline and 24 weeks