To evaluate the impact of a Low Carbohydrate Ketogenic Diet (LCKD) weight loss program and compare to the standard of care program established for patients with Non-Alcoholic Fatty Liver Disease (NAFLD) on: (1) Liver fat and liver stiffness scores, (2) lipid profile and insulin sensitivity; and (3) depression scores and quality of life, and (4) Cardiometabolic measures such as cardiopulmonary exercise test (CPET) and transthoracic echocardiogram (TTE).
This prospective pilot pragmatic trial will investigate the role of a LCKD weight loss program for obese patients (BMI ≥30 kg/m2) and compare it to the group of known obese NAFLD patients who receive dietetic counseling as part of their standard of care in a dedicated NAFLD program. All participants (n=50) will be recruited at Virginia Commonwealth University (VCU). Patients will do initial paperwork including Questionnaires QOL, eating disorder screen, depression screen: QOL, eating disorder screen and depression screen. Labwork: Data will be collected from routine care labwork to include a fasting cholesterol panel, insulin, A1c and comprehensive panel (if they have not received these labs in the preceding 3 months), and at 6 and 12 months. A1c will be collected at 3,6,9 months as well (if A1c \>/=7), or just additionally at 6 months if A1c \<7 Study labs will be collected: Blood at 0, 3, 6 and 12 months Urine, stool and saliva at 0, 1, 3 and 12 months Fibroscan will be done at 0, 3, 6 and 12 months Echo/CPET testing and Room calorimetry will be offered and the patients agreeing to do this will have them done at 0, 3 and 12 months
Study Type
OBSERVATIONAL
Enrollment
54
Observational study of liver fat and stiffness and cardiometabolic parameters comparing two different standard of care dietary regimens
Virginia Commonwealth University
Richmond, Virginia, United States
Change in liver fat and stiffness scores compared to control group as well as intrasubject trend
Performed with a fibroscan
Time frame: 0, 3, 6, 12 months
Change in Cardiometabolic labs
Lipids, A1c, Insulin, comprehensive metabolic panel
Time frame: 0, 6, 12 months (3 and 9 months for A1c if >7
Other specialized testing
Echo, cardiopulmonary exercise testing, room calorimetry
Time frame: Only to a few of the eligible patients, 0, 3, 12 months
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