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New treatment option for Liver Transplantation
Official title Mediterranean Diet Post-liver Transplantation
ClinicalTrials.gov ID: NCT04672863
What this study is testing
- What it's testing
- The purpose of this study is to study the effects of a structured Mediterranean dietary program on prevention of weight gain, promotion of heart health and prevention of fatty liver disease after liver transplantation.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients ≥ 18 years of age undergoing primary liver transplant
- Ascites-adjusted BMI ≥ 25 kg/m2
- Acceptable graft function (total bilirubin level \< 5 mg/dL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)
You likely can't join if
- Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology
- Untreated post-transplant vascular complications or biliary strictures
- Multi-organ transplantation
- Urine protein excretion ≥2.0 g/day
- Uncontrolled diabetes mellitus (HbA1c \> 10%)
- Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat...
See the full eligibility criteria
- Adult patients ≥ 18 years of age undergoing primary liver transplant
- Ascites-adjusted BMI ≥ 25 kg/m2
- Acceptable graft function (total bilirubin level \< 5 mg/dL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)
- Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology
- Untreated post-transplant vascular complications or biliary strictures
- Multi-organ transplantation
- Urine protein excretion ≥2.0 g/day
- Uncontrolled diabetes mellitus (HbA1c \> 10%)
- Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat intolerance, neurological, psychiatric or endocrine disorders
- Active eating disorder (e.g. bulimia nervosa, anorexia nervosa)
- History of bariatric surgery
- Pregnancy or planning on pregnancy in the next year
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.