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Observational Study on Malnutrition in Cirrhosis

This observational study is looking into why people with cirrhosis (a severe liver disease) often lose muscle and fat. Researchers believe a protein called myostatin might play a role. They will compare myostatin levels in muscle tissue from people with cirrhosis who are having liver transplant surgery to healthy individuals having other abdominal surgeries. The main goal is to see if there's a difference in myostatin expression between these two groups. You could be eligible if you are between 18 and 70 years old and are already scheduled for certain abdominal surgeries. The study aims to enroll 40 participants.

Study design
This is an observational study that plans to enroll 40 participants. It compares individuals with cirrhosis to healthy controls.
What's involved
If you participate, a small sample of your rectus abdominis muscle will be taken during your already scheduled surgery. This biopsy will be measured at 15 minutes.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03121404

Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting

Recruiting
Not specifiedAges 18–70Observational
The Cleveland Clinic
~40 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:Rectus abdominis muscle biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the difference in myostatin expression between healthy control and cirrhosis patients
Measured over 15 minute biopsy

Conditions

Cirrhosis

Explore related trials

Cirrhosis

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Annette Bellar, MSLA
[email protected]
216-636-5247
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Determine the difference in myostatin expression between healthy control and cirrhosis patients15 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.