[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03121404":3,"trial-entities:NCT03121404":94,"trial-summary:NCT03121404":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":41,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":60,"locations":63,"central_contacts":85,"overall_officials":91,"references":92,"see_also_links":93},"NCT03121404","08-546","Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting","RECRUITING","2027-12-31","2026-01","2026-01-09","2008-11-14","The Cleveland Clinic","OTHER",true,"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.",null,[18],"Cirrhosis",[],"OBSERVATIONAL",[],{"count":23,"type":24},40,"ESTIMATED",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30},"PROCEDURE","Rectus abdominis muscle biopsy","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.",[31,32],"Cirrhosis Patient","Healthy Controls",[34],{"measure":35,"description":36,"timeFrame":37},"Determine the difference in myostatin expression between healthy control and cirrhosis patients","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.","15 minute biopsy",[],"ALL","18 Years","70 Years",{"inclusion":43,"exclusion":46,"raw_text":59},[44,45],"Age 18-70 years","Patients undergoing abdominal surgery (liver transplantation or other surgery)",[47,48,49,50,51,52,53,54,55,56,57,58],"Average daily alcohol intake \\> 20 g in women and \\> 30 g in men","Diabetes or a fasting serum glucose \\> 100 mg\u002FdL","Hyper- \u002F hypo- thyroidism","Renal disease with serum creatinine \\> 1.4 mg\u002FdL","Folate or vitamin B12 deficiency","Active intravenous drug use","History of bowel surgery or gastric bypass surgery","Medications\u002Fsupplements 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)","Inclusion Criteria:\n\n* Age 18-70 years\n* Patients undergoing abdominal surgery (liver transplantation or other surgery)\n\nControl\n\n1. non liver transplant donor\n2. Elective abdominal surgery (cholecystectomy, diverticulosis, acute gastrointestinal bleeding in the absence of exclusion criteria)\n\nExclusion Criteria:\n\n* Exclusion criteria (all subjects)\n* Average daily alcohol intake \\> 20 g in women and \\> 30 g in men\n* Diabetes or a fasting serum glucose \\> 100 mg\u002FdL\n* Hyper- \u002F hypo- thyroidism\n* Renal disease with serum creatinine \\> 1.4 mg\u002FdL\n* Folate or vitamin B12 deficiency\n* Active intravenous drug use\n* History of bowel surgery or gastric bypass surgery\n* Medications\u002Fsupplements that affect fat mass or protein mass (creatine, glucocorticoids)\n* Pregnancy\n* Chronic diseases that result in cachexia (renal, cardiac, pulmonary, hematologic, cancer)\n* Hepatocellular cancer\n\nExclusion criteria (controls)\n\n* Evidence of malnutrition as quantified by triceps skinfold thickness, mid arm muscle area and creatinine height index)",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":82},"Cleveland Clinic Foundation","Cleveland","Ohio","44195","United States",[71,76,79],{"name":72,"role":73,"phone":74,"email":75},"Annette Bellar, BS","CONTACT","216-636-5247","bellara@ccf.org",{"name":77,"role":73,"phone":74,"email":78},"Megan Villareal, BS","villarm@ccf.org",{"name":80,"role":81},"Srinivasan Dasarathy, MD","PRINCIPAL_INVESTIGATOR",{"lat":83,"lon":84},41.4995,-81.69541,[86,88],{"name":87,"role":73,"phone":74,"email":75},"Annette Bellar, MSLA",{"name":89,"role":73,"email":90},"Revathi Penumatsa","penumar@ccf.org",[],[],[],{"nct_id":4,"conditions":95,"biomarkers":96},[18],[],{"nct_id":4,"found":14,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an observational study that plans to enroll 40 participants. It compares individuals with cirrhosis to healthy controls.","completed","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.","Not specified.",99,"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.","Not stated in the trial record.",[],"v2"]