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

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04145427
• Other study ID #: HM20017667
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: Virginia Commonwealth University
• Contact: Nathaniel W Brigle, BS
• Phone: 804-827-1788
• Email: nathaniel.brigle[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Weight Gain

Intervention

Behavioral:
• Control
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
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in metabolic flexibility	This will be measured in whole room calorimeter and reported as respiratory quotient	baseline to 6 months
Secondary	Change in LDL-C	LDL-cholesterol will be measured using a fasting blood draw and a standard lipid panel.	baseline to 6 months
Secondary	Change in total cholesterol	Total cholesterol will be measured using a fasting blood draw and a standard lipid panel.	baseline to 6 months
Secondary	Change in small dense low-density lipoprotein	Small dense LDL will be measured using a fasting blood draw and a standard lipid panel.	baseline to 6 months
Secondary	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	baseline to 6 months