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Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting

Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03121404
Enrollment
40
Registered
2017-04-20
Start date
2008-11-14
Completion date
2027-12-31
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Brief summary

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.

Interventions

PROCEDURERectus abdominis muscle biopsy

Patients who will already be having either liver transplant surgery or abdominal surgery will have a biopsy of their rectus abdominis muscle during the time of surgery.

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-70 years * Patients undergoing abdominal surgery (liver transplantation or other surgery) Control 1. non liver transplant donor 2. Elective abdominal surgery (cholecystectomy, diverticulosis, acute gastrointestinal bleeding in the absence of

Exclusion criteria

)

Design outcomes

Primary

MeasureTime frameDescription
Determine the difference in myostatin expression between healthy control and cirrhosis patients15 minute biopsyThe primary outcome of this study is to determine the difference in expression of myostatin in skeletal muscle in a one time biopsy of the Rectus abdominis muscle between healthy controls and cirrhotic patients.

Countries

United States

Contacts

Primary ContactAnnette Bellar, MSLA
bellara@ccf.org216-636-5247
Backup ContactRevathi Penumatsa
penumar@ccf.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026