Weight Gain
Conditions
Keywords
Liver Transplant, Low Carbohydrate Diet
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.
Interventions
BEHAVIORALControl
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.
BEHAVIORALLCD
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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | baseline to 6 months | Weight will be measured on a standardized scale in kilograms that will be zeroed out prior to the measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in metabolic flexibility | baseline to 6 months | This will be measured in whole room calorimeter and reported as respiratory quotient |
| Change in LDL-C | baseline to 6 months | LDL-cholesterol will be measured using a fasting blood draw and a standard lipid panel. |
| Change in total cholesterol | baseline to 6 months | Total cholesterol will be measured using a fasting blood draw and a standard lipid panel. |
| Change in small dense low-density lipoprotein | baseline to 6 months | Small dense LDL will be measured using a fasting blood draw and a standard lipid panel. |
| Change in adiposity | 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 |
Countries
United States
Outcome results
None listed