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

Not Applicable

Completed

• Conditions: Weight Gain
• Interventions: Behavioral: LCD; Behavioral: Control

• Registration Number: NCT04145427
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2020-02-27
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Carbohydrate Diet	LCD	This arm will be randomized to low carbohydrate diet
Standard Dietary Advice Control Group	Control	This arm will be randomized to control diet

Primary Outcome Measures

Name	Time	Method
Change in weight	baseline to 6 months	Weight will be measured on a standardized scale in kilograms that will be zeroed out prior to the measurement

Secondary Outcome Measures

Name	Time	Method
Change in metabolic flexibility	baseline to 6 months	This will be measured in whole room calorimeter and reported as respiratory quotient
Change in LDL-C	baseline to 6 months	LDL-cholesterol will be measured using a fasting blood draw and a standard lipid panel.
Change in total cholesterol	baseline to 6 months	Total cholesterol will be measured using a fasting blood draw and a standard lipid panel.
Change in small dense low-density lipoprotein	baseline to 6 months	Small dense LDL will be measured using a fasting blood draw and a standard lipid panel.
Change in adiposity	baseline to 6 months	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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States