Ignite Creation Date:
2024-05-06 @ 2:59 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02174783
Status:
TERMINATED
Last Update Posted:
2017-03-14
First Post:
2014-06-23
Brief Title:
Mediterranean Diet and Protein-Sparing Modified Diet for Metabolic Syndrome in Liver Transplant Recipients
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None