Examining malnutrition mechanisms in cirrhosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the mechanisms of malnutrition in patients with cirrhosis, particularly focusing on the role of myostatin in muscle and fat mass loss. It will compare 16 cirrhotic patients undergoing liver transplantation with 16 healthy controls undergoing elective abdominal surgery. Nutritional assessments will include anthropometry, dual energy x-ray absorptiometry (DEXA), and bioelectrical impedance analysis (BIA), alongside rectus abdominis muscle biopsies to analyze myostatin expression and related signaling pathways. The goal is to better understand how malnutrition develops in cirrhosis and its implications for patient outcomes.

Why it matters

Who can join: the full rules

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)

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)

Where it's running

• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Annette Bellar, MSLA
• Email: bellara@ccf.org
• Phone: 216-636-5247

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.