Evaluation of Liver and Cardiometabolic Health Benefits on Low Carbohydrate Ketogenic Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in liver fat and stiffness scores compared to control group as well as intrasubject trend
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in liver fat and stiffness scores compared to control group as well as intrasubject trend
时间窗: 0, 3, 6, 12 months
Performed with a fibroscan
次要结局
- Other specialized testing(Only to a few of the eligible patients, 0, 3, 12 months)
- Change in Cardiometabolic labs(0, 6, 12 months (3 and 9 months for A1c if >7)