Examining malnutrition mechanisms in cirrhosis patients
Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting
The Cleveland Clinic · NCT03121404
This study is trying to understand how malnutrition happens in people with cirrhosis by looking at muscle and fat loss, and comparing them to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT03121404 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with cirrhosis undergoing liver transplantation or other abdominal surgeries.
Not a fit: Patients with chronic diseases causing cachexia, active intravenous drug users, or those with significant alcohol intake may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional management strategies for cirrhotic patients, potentially enhancing their outcomes before and after liver transplantation.
How similar studies have performed: While the specific mechanisms of myostatin in cirrhosis are less explored, similar studies have shown promising results in understanding malnutrition in other chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Annette Bellar, MSLA
- Email: bellara@ccf.org
- Phone: 216-636-5247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cirrhosis