Fatty Liver, Ketogenic Dieting, Obesity
Conditions
Keywords
Ketosis, NAFLD, Obesity
Brief summary
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).
Detailed description
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
Interventions
OTHERFibroscan changes with different diets
Observational study of liver fat and stiffness and cardiometabolic parameters comparing two different standard of care dietary regimens
Sponsors
Obesity Treatment Foundation
Virginia Commonwealth University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The inclusion criteria include patients aged 18 years and older, BMI ≥ 30, ALT (alanine transferase) \> 19 (female) and \> 30 (male) or radiographic evidence of hepatic parenchymal disease and seen in either the PIs weight loss clinic or a patient in the VCU NAFLD (non-alcoholic fatty liver disease) program.
Exclusion criteria
* Patients will be excluded if they have known other liver disease such as viral hepatitis, autoimmune hepatitis, liver transplant, severely ill, weekly alcohol use (\>14 drinks in men and \>7 drinks in women), HIV, pregnant females, those\< 18 years, and prisoners.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in liver fat and stiffness scores compared to control group as well as intrasubject trend | 0, 3, 6, 12 months | Performed with a fibroscan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiometabolic labs | 0, 6, 12 months (3 and 9 months for A1c if >7 | Lipids, A1c, Insulin, comprehensive metabolic panel |
| Other specialized testing | Only to a few of the eligible patients, 0, 3, 12 months | Echo, cardiopulmonary exercise testing, room calorimetry |
Countries
United States
Outcome results
None listed