Mediterranean Diet and Protein-Sparing Modified Diet for Metabolic Syndrome in Liver Transplant Recipients
| Status: | Terminated |
|---|---|
| Conditions: | Obesity Weight Loss, Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2017 |
| Start Date: | June 2014 |
| End Date: | April 2015 |
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
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.
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.
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.
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.
Inclusion Criteria:
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:
1. Triglyceride (TG)>150 mg/dl or specific treatment for this lipid abnormality
2. HDL <40 mg/dl in females and <50 mg/dl in males or specific treatment of this lipid
abnormality
3. Systolic BP >130 or diastolic BP >85 mm Hg or treatment for previously diagnosed
hypertension
4. Fasting plasma glucose >100 mg/dl or previously diagnosed type 12 diabetes
Exclusion Criteria:
- 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
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