- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03121404
Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting
May 6, 2024 updated by: Srinivasan Dasarathy, The Cleveland Clinic
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Annette Bellar, MSLA
- Phone Number: 216-636-5247
- Email: bellara@ccf.org
Study Contact Backup
- Name: Revathi Penumatsa
- Email: penumar@ccf.org
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
-
Contact:
- Megan Villareal, BS
- Phone Number: 216-636-5247
- Email: villarm@ccf.org
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Contact:
- Annette Bellar, BS
- Phone Number: 216-636-5247
- Email: bellara@ccf.org
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Principal Investigator:
- Srinivasan Dasarathy, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients will be identified from the Cleveland Clinic transplant list.
All subjects with cirrhosis of any etiology who will undergo liver transplantation will make up the group of cirrhosis patients.
The controls will be patients without cirrhosis that are undergoing abdominal surgery will be identified from the operating room list at Cleveland Clinic.
Rectus abdominis muscle biopsies will be obtained directly after induction of anesthesia for the procedure.
Description
Inclusion Criteria:
- Age 18-70 years
- Patients undergoing abdominal surgery (liver transplantation or other surgery)
Control
- non liver transplant donor
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cirrhosis Patient
Patients will be identified from the transplant list.
Inclusion criteria will be all subjects with cirrhosis of any etiology who will undergo liver transplantation. .
Rectus abdominis muscle biopsy will be obtained directly after induction of anesthesia for the procedure.
In addition patients will have anthropometric measurements taken within 2 weeks of surgery.
For the cirrhotic patients this includes hand grip test and dual energy x-ray absorption (DEXA).
|
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.
|
Healthy Controls
Controls will be identified from the abdominal surgery operating room lists at Cleveland Clinic.
Rectus abdominis muscle biopsy will be obtained directly after induction of anesthesia for the procedure.
In addition patients will have anthropometric measurements taken within 2 weeks of surgery which will not include DEXA or hand grip test.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the difference in myostatin expression between healthy control and cirrhosis patients
Time Frame: 15 minute biopsy
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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.
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15 minute biopsy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 14, 2008
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
April 12, 2017
First Submitted That Met QC Criteria
April 17, 2017
First Posted (Actual)
April 20, 2017
Study Record Updates
Last Update Posted (Actual)
May 7, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-546
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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