Impact of a LCD on Metabolic Inflexibility and Cardiovascular Risk in Liver Transplant Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Weight Gain
• Intervention / Treatment: Behavioral: LCD; Behavioral: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathaniel W Brigle, BS; Phone Number: 804-827-1788; Email: nathaniel.brigle@vcuhealth.org
• Study Contact Backup: Name: Danielle Kirkman, PhD; Email: dlkirkman@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years
• At least 12 months after LT
• Obese (BMI > 30kg/m2)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Carbohydrate Diet; This arm will be randomized to low carbohydrate diet	Behavioral: LCD; Initial Weight Loss consultation 1.5 hour session on how to do implement healthy diet and then have a 2-week follow-up class. Information on how to maintain a LCD will be provided provided. 4 lifestyle coaching sessions Monthly visits for behavioral and dietary coaching as well as medication management.
Active Comparator: Standard Dietary Advice Control Group; This arm will be randomized to control diet	Behavioral: Control; Initial Weight Loss consultation 1.5 hour session on how to do implement healthy diet and then have a 2-week follow-up class. Information on how to maintain a healthy combination protein, fat and vegetables daily will be provided provided. 4 lifestyle coaching sessions Monthly visits for behavioral and dietary coaching as well as medication management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight	Weight will be measured on a standardized scale in kilograms that will be zeroed out prior to the measurement	baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in metabolic flexibility	This will be measured in whole room calorimeter and reported as respiratory quotient	baseline to 6 months
Change in LDL-C	LDL-cholesterol will be measured using a fasting blood draw and a standard lipid panel.	baseline to 6 months
Change in total cholesterol	Total cholesterol will be measured using a fasting blood draw and a standard lipid panel.	baseline to 6 months
Change in small dense low-density lipoprotein	Small dense LDL will be measured using a fasting blood draw and a standard lipid panel.	baseline to 6 months
Change in adiposity	This will be measured on body composition MRI where subcutaneous and visceral fat will be quantified. Subcutaneous fat and visceral fat volume will measured on body composition MRI in liters (L) and standardized to body height and will be reported as liter/m2	baseline to 6 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Mohammad Siddiqui, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Liver Transplant, Low Carbohydrate Diet
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: HM20017667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No