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OpenTrials
Completed

NCT Number: NCT03141008

Evaluation of Liver and Cardiometabolic Health Benefits on Low Carbohydrate Ketogenic Diet

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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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibroscan changes with different diets

Other

Observational study of liver fat and stiffness and cardiometabolic parameters comparing two different standard of care dietary regimens

Primary outcomes

  1. Change in liver fat and stiffness scores compared to control group as well as intrasubject trend

    Time frame: 0, 3, 6, 12 months

    Performed with a fibroscan

Secondary outcomes

  1. Change in Cardiometabolic labs

    Time frame: 0, 6, 12 months (3 and 9 months for A1c if >7

    Lipids, A1c, Insulin, comprehensive metabolic panel

  2. Other specialized testing

    Time frame: Only to a few of the eligible patients, 0, 3, 12 months

    Echo, cardiopulmonary exercise testing, room calorimetry

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Obesity Treatment Foundation

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 4, 2017
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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