Impact of a Low Carbohydrate Diet (LCD) on Metabolic Inflexibility and Cardiovascular Risk in Liver Transplant (LT) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in weight
研究概览
简要总结
This study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on the heart and blood vessel health.
详细描述
Weight gain often occurs following a liver transplant. This weight gain is problematic as it leads to many other health problems. The reasons of this weight gain are still poorly understood. To better understand weight gain, this study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on heart and blood vessel health.
This study will help researchers to better understand weight gain after a transplant. This knowledge will help doctors prevent weight gain after a liver transplant and therefore improve the health of liver transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •At least 12 months after LT
- •Obese (BMI > 30kg/m2)
排除标准
- •Acute cellular or chronic rejection within 3 months
- •Post-LT liver or non-liver related malignancy
- •Active viral hepatitis (B or C), autoimmune hepatitis
- •Untreated biliary strictures or vascular complications (i.e. hepatic artery thrombosis)
- •Poorly controlled Diabetes mellitus
- •Relapse of alcohol abuse after LT
- •Stage 5 Chronic Kidney Disease
- •Current pregnancy
研究组 & 干预措施
Low Carbohydrate Diet
This arm will be randomized to low carbohydrate diet
干预措施: LCD (Behavioral)
Standard Dietary Advice Control Group
This arm will be randomized to control diet
干预措施: Control (Behavioral)
结局指标
主要结局
Change in weight
时间窗: baseline to 6 months
Weight will be measured on a standardized scale in kilograms that will be zeroed out prior to the measurement
次要结局
- Change in LDL-C(baseline to 6 months)
- Change in total cholesterol(baseline to 6 months)
- Change in metabolic flexibility(baseline to 6 months)
- Change in small dense low-density lipoprotein(baseline to 6 months)
- Change in adiposity(baseline to 6 months)