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

Primary Purpose

Weight Gain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Control

LCD

About this trial

This is an interventional prevention trial for Weight Gain focused on measuring Liver Transplant, Low Carbohydrate Diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Carbohydrate Diet

Standard Dietary Advice Control Group

Arm Description

This arm will be randomized to low carbohydrate diet

This arm will be randomized to control diet

Outcomes

Primary Outcome Measures

Change in weight

Weight will be measured on a standardized scale in kilograms that will be zeroed out prior to the measurement

Secondary Outcome Measures

Change in metabolic flexibility

This will be measured in whole room calorimeter and reported as respiratory quotient

Change in LDL-C

LDL-cholesterol will be measured using a fasting blood draw and a standard lipid panel.

Change in total cholesterol

Total cholesterol will be measured using a fasting blood draw and a standard lipid panel.

Change in small dense low-density lipoprotein

Small dense LDL will be measured using a fasting blood draw and a standard lipid panel.

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

Full Information

NCT ID

NCT04145427

First Posted

October 28, 2019

Last Updated

October 19, 2023

Sponsor

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT04145427

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 27, 2020 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Gain

Keywords

Liver Transplant, Low Carbohydrate Diet

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low Carbohydrate Diet

Arm Type

Experimental

Arm Description

This arm will be randomized to low carbohydrate diet

Arm Title

Standard Dietary Advice Control Group

Arm Type

Active Comparator

Arm Description

This arm will be randomized to control diet

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

LCD

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in weight

Description

Weight will be measured on a standardized scale in kilograms that will be zeroed out prior to the measurement

Time Frame

baseline to 6 months

Secondary Outcome Measure Information:

Title

Change in metabolic flexibility

Description

This will be measured in whole room calorimeter and reported as respiratory quotient

Time Frame

baseline to 6 months

Title

Change in LDL-C

Description

LDL-cholesterol will be measured using a fasting blood draw and a standard lipid panel.

Time Frame

baseline to 6 months

Title

Change in total cholesterol

Description

Total cholesterol will be measured using a fasting blood draw and a standard lipid panel.

Time Frame

baseline to 6 months

Title

Change in small dense low-density lipoprotein

Description

Small dense LDL will be measured using a fasting blood draw and a standard lipid panel.

Time Frame

baseline to 6 months

Title

Change in adiposity

Description

Time Frame

baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nathaniel W Brigle, BS

Phone

804-827-1788

nathaniel.brigle@vcuhealth.org

First Name & Middle Initial & Last Name or Official Title & Degree

Danielle Kirkman, PhD

dlkirkman@vcu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad Siddiqui, MD

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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