NCT03121404 Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting
| NCT ID | NCT03121404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2008-11-14 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2008-11-14 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03121404 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03121404 currently recruiting?
Yes, NCT03121404 is actively recruiting participants. Contact the research team at bellara@ccf.org for enrollment information.
Where is the NCT03121404 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT03121404 clinical trial?
NCT03121404 is sponsored by The Cleveland Clinic. The trial plans to enroll 40 participants.