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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Weight Gain

Treatments: Behavioral: Control; Behavioral: LCD

Study type: Interventional

Funder types: Other

Identifiers

NCT04145427

HM20017667

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Low Carbohydrate Diet

Experimental group

Description:

This arm will be randomized to low carbohydrate diet

Treatment:

Behavioral: LCD

Standard Dietary Advice Control Group

Active Comparator group

Description:

This arm will be randomized to control diet

Treatment:

Behavioral: Control