Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Location contact
Annette Bellar, BS
CONTACT
Megan Villareal, BS
CONTACT
Srinivasan Dasarathy, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT03121404
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Observational
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Annette Bellar, BS
CONTACT
Megan Villareal, BS
CONTACT
Srinivasan Dasarathy, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Control
Exclusion criteria
Exclusion criteria
(controls)
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.
Time frame: 15 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.
Contact information is provided by the study sponsor or research team.
Annette Bellar, MSLA
CONTACT
Revathi Penumatsa
CONTACT
The Cleveland Clinic
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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