RECRUITING

Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cirrhosis is characterized by loss of muscle as well as fat mass, which increases morbidity and mortality before, during, and after liver transplantation. A common mechanism for the reduced muscle and fat mass in cirrhosis is an increased expression of the TGF (transforming growth factor)beta superfamily member, myostatin, in the muscle and adipose tissue. The present study will examine the expression of myostatin, its receptor and intracellular signaling pathways in the skeletal muscle and mesenteric adipose tissue in cirrhotic patients undergoing liver transplantation as compared to healthy controls undergoing planned abdominal surgery. 16 cirrhotic patients will be identified from the transplant list, and 16 healthy controls from outpatient surgery lists. Nutritional assessment will be performed, including anthropometry (triceps skinfold thickness, mid arm circumference), dual energy x-ray absorptiometry (DEXA), and bioelectrical impedance analysis (BIA). Rectus abdominis muscle tissue and omental fat tissue will be harvested in the operating room, and the expression of signaling proteins involved in skeletal muscle protein synthesis will be quantified. The investigator will also quantify the expression of genes involved in lipolysis and lipid synthesis. The investigator anticipates that the expression of myostatin will be higher in the skeletal muscle and adipose tissue of cirrhotics as compared to controls. There will be a reduction in the expression of the signaling proteins that regulate skeletal muscle protein synthesis, as well as the expression of genes regulating lipogenesis. The increased expression of myostatin will also correlate with reduced anthropometric and DEXA measurements of lean body mass and fat mass.

Official Title

Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting

Quick Facts

Study Start:2008-11-14
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03121404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-70 years
  2. * Patients undergoing abdominal surgery (liver transplantation or other surgery)
  3. 1. non liver transplant donor
  4. 2. Elective abdominal surgery (cholecystectomy, diverticulosis, acute gastrointestinal bleeding in the absence of exclusion criteria)
  1. * Exclusion criteria (all subjects)
  2. * Average daily alcohol intake \> 20 g in women and \> 30 g in men
  3. * Diabetes or a fasting serum glucose \> 100 mg/dL
  4. * Hyper- / hypo- thyroidism
  5. * Renal disease with serum creatinine \> 1.4 mg/dL
  6. * Folate or vitamin B12 deficiency
  7. * Active intravenous drug use
  8. * History of bowel surgery or gastric bypass surgery
  9. * Medications/supplements that affect fat mass or protein mass (creatine, glucocorticoids)
  10. * Pregnancy
  11. * Chronic diseases that result in cachexia (renal, cardiac, pulmonary, hematologic, cancer)
  12. * Hepatocellular cancer
  13. * Evidence of malnutrition as quantified by triceps skinfold thickness, mid arm muscle area and creatinine height index)

Contacts and Locations

Study Contact

Annette Bellar, MSLA
CONTACT
216-636-5247
bellara@ccf.org
Revathi Penumatsa
CONTACT
penumar@ccf.org

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2008-11-14
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2008-11-14
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cirrhosis