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Completed

NCT Number: NCT04145427

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in weight

    Time frame: baseline to 6 months

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

Secondary outcomes

  1. Change in metabolic flexibility

    Time frame: baseline to 6 months

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

  2. Change in LDL-C

    Time frame: baseline to 6 months

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

  3. Change in total cholesterol

    Time frame: baseline to 6 months

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

  4. Change in small dense low-density lipoprotein

    Time frame: baseline to 6 months

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

  5. Change in adiposity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2019
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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