The Safety and Efficacy of Mediterranean Diet and Protein-Sparing Modified Diet on Obesity and Metabolic Syndrome in Liver Transplant Recipients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
Many metabolic complications can develop after liver transplant including: diabetes, high blood pressure, obesity, heart attacks and stroke. The goal of this study is to look at the safety and effect of 2 well known and established diet regimens on the people who had a prior liver transplant and investigate whether it helps with the control of these comorbidities.
详细描述
The Mediterranean diet has been shown to be effective in improving hepatic steatosis, insulin sensitivity, diabetes control and reducing cardiovascular risk in adult patients, but there is no data available for patients who underwent liver transplant. The protein-sparing modified fast (PSMF) diet has been used for years at the Cleveland Clinic to treat adult patients with obesity-related medical problems, but its safety and efficacy has not been established in liver transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adult patients > 18 years old who had a successful liver transplant at least 1 year prior to enrollment who also have a BMI>30 with previous failed attempts at weight loss via conventional methods. In addition to one of the following:
- •Triglyceride (TG)>150 mg/dl or specific treatment for this lipid abnormality
- •HDL <40 mg/dl in females and <50 mg/dl in males or specific treatment of this lipid abnormality
- •Systolic BP >130 or diastolic BP >85 mm Hg or treatment for previously diagnosed hypertension
- •Fasting plasma glucose >100 mg/dl or previously diagnosed type 12 diabetes
排除标准
- •Significant behavioral issues that would interfere with compliance
- •Lack of readiness to change (pre-contemplation, contemplation or preparation stages)
- •Previous bariatric surgery
- •Pregnant or planning to become pregnant
- •History of a documented eating disorder (e.g. bulimia)
- •History of kidney stones
研究组 & 干预措施
Control group
Standard of care group
干预措施: Control group (Other)
Mediterranean diet
Mediterranean diet for 6 months
干预措施: Mediterranean diet (Other)
Protein-Sparing Modified Fast (PSMF)
PSMF for 6 months
干预措施: Protein-Sparing Modified Fast (PSMF) (Other)
结局指标
主要结局
Weight loss
时间窗: 6 months
次要结局
- Change in Hb A1c compared to baseline(6 months)
- Change in HDL and LDL compared to baseline(6 months)
- Number of Participants with Serious and Non-Serious Adverse Events(6 months)
- Change in blood pressure compared to baseline(6 months)
- Change in triglyceride compared to baseline(6 months)