Virginia Commonwealth University
Richmond, Virginia, 23298, United States
NCT Number: NCT03141008
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).
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Notify Me18 year and older
All sexes
Observational
Richmond, Virginia, 23298, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observational study of liver fat and stiffness and cardiometabolic parameters comparing two different standard of care dietary regimens
Time frame: 0, 3, 6, 12 months
Performed with a fibroscan
Time frame: 0, 6, 12 months (3 and 9 months for A1c if >7
Lipids, A1c, Insulin, comprehensive metabolic panel
Time frame: Only to a few of the eligible patients, 0, 3, 12 months
Echo, cardiopulmonary exercise testing, room calorimetry
Virginia Commonwealth University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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