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

NCT04145427 | Completed

• 1 other identifier: HM20017667
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Gain

Keywords

Liver Transplant, Low Carbohydrate Diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in metabolic flexibility

  baseline to 6 months

• Change in LDL-C

  baseline to 6 months

• Change in total cholesterol

  baseline to 6 months

• Change in small dense low-density lipoprotein

  baseline to 6 months

• Change in adiposity

  baseline to 6 months

Study Arms (2)

Low Carbohydrate Diet

EXPERIMENTAL

This arm will be randomized to low carbohydrate diet

Behavioral: LCD

Standard Dietary Advice Control Group

ACTIVE COMPARATOR

This arm will be randomized to control diet

Behavioral: Control

Interventions

Control BEHAVIORAL

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.

Standard Dietary Advice Control Group

LCD BEHAVIORAL

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.

Low Carbohydrate Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Siddiqui, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: February 27, 2020
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)