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NCT Number: NCT03121404

Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-70 years
  • Patients undergoing abdominal surgery (liver transplantation or other surgery)

Control

  • non liver transplant donor
  • Elective abdominal surgery (cholecystectomy, diverticulosis, acute gastrointestinal bleeding in the absence of exclusion criteria)

Exclusion criteria

  • Exclusion criteria (all subjects)
  • Average daily alcohol intake > 20 g in women and > 30 g in men
  • Diabetes or a fasting serum glucose > 100 mg/dL
  • Hyper- / hypo- thyroidism
  • Renal disease with serum creatinine > 1.4 mg/dL
  • Folate or vitamin B12 deficiency
  • Active intravenous drug use
  • History of bowel surgery or gastric bypass surgery
  • Medications/supplements that affect fat mass or protein mass (creatine, glucocorticoids)
  • Pregnancy
  • Chronic diseases that result in cachexia (renal, cardiac, pulmonary, hematologic, cancer)
  • Hepatocellular cancer

Exclusion criteria

(controls)

  • Evidence of malnutrition as quantified by triceps skinfold thickness, mid arm muscle area and creatinine height index)

Treatment and study plan

Rectus abdominis muscle biopsy

Procedure

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.

Primary outcomes

  1. Determine the difference in myostatin expression between healthy control and cirrhosis patients

    Time frame: 15 minute biopsy

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annette Bellar, MSLA

CONTACT

[email protected]

216-636-5247

Revathi Penumatsa

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2008
Primary completion
2026
Study completion
2027
First posted
Apr 20, 2017
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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