跳至主要内容
临床试验/NCT04145427
NCT04145427已完成不适用

Impact of a Low Carbohydrate Diet (LCD) on Metabolic Inflexibility and Cardiovascular Risk in Liver Transplant (LT) Patients

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
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

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

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 metabolic flexibility(baseline to 6 months)
  • Change in LDL-C(baseline to 6 months)
  • Change in total cholesterol(baseline to 6 months)
  • Change in small dense low-density lipoprotein(baseline to 6 months)
  • Change in adiposity(baseline to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验