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Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis

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ClinicalTrials.gov Identifier: NCT03225677
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Srinivasan Dasarathy, The Cleveland Clinic

Brief Summary:
To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in cirrhotic patients by using multiple tracers and single muscle biopsies.

Condition or disease Intervention/treatment
Cirrhosis Procedure: blood draw and muscle biopsy

Detailed Description:
The goal of this study is to identify the molecular regulatory mechanisms that result in loss of skeletal muscle in cirrhotic patients. Current strategies involve prolonged tracer infusion and multiple muscle biopsies. We will use an innovative approach to determine the rates of skeletal muscle protein synthesis and breakdown using multiple tracers administered at short intervals followed by a single muscle biopsy. These studies are likely to provide a conceptual advance in determining the cellular and molecular responses of the skeletal muscle in cirrhosis.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Multiple Tracer Using Single Muscle Biopsy Technique in Evaluating Protein Synthesis and Break Down in Muscles of Cirrhotic Patients
Actual Study Start Date : July 3, 2017
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Cirrhosis

Group/Cohort Intervention/treatment
Patients with Cirrhosis
Patients with a diagnosis of cirrhosis will have a blood draw and muscle biopsy will be performed.
Procedure: blood draw and muscle biopsy
One venous catheter will be used for bolus injection of multiple labeled AA at the beginning .The second venous catheter will inserted in the other arm for 5 ml of arterialized venous blood draw.Following the infusions, a single muscle biopsy will be performed from the vastus lateralis of the thigh using the Bergstromm needle.

controls
control group should have serum ALT and AST within normal range and a blood draw and muscle biopsy will be performed
Procedure: blood draw and muscle biopsy
One venous catheter will be used for bolus injection of multiple labeled AA at the beginning .The second venous catheter will inserted in the other arm for 5 ml of arterialized venous blood draw.Following the infusions, a single muscle biopsy will be performed from the vastus lateralis of the thigh using the Bergstromm needle.




Primary Outcome Measures :
  1. Fractional Synthesis Rate [ Time Frame: 4 hours ]
    Fractional synthesis rate (FSR)for each patient is measured by the rate of tracer incorporation from the MIF pool to the bound pool.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Study population: Adults with the diagnosis of cirrhosis will be recruited from the hepatology inpatient service, outpatient clinics and liver transplant clinics at the Cleveland Clinic Foundation. The diagnosis of cirrhosis will be based on liver biopsy and/or clinical, biochemical, and imaging criteria. Will include patient with Child Pugh score from A5- to B7
Criteria

Inclusion Criteria:

  • The diagnosis of cirrhosis based on liver biopsy and/or clinical, biochemical, and imaging criteria.
  • Patients with Child Pugh score from A5- to B7
  • Control group: Subject in control group should have serum ALT and AST within normal range.

Exclusion Criteria for both groups (cirrhotic and control) are:

  • diabetes
  • cancer
  • kidney failure
  • pregnancy
  • recent surgery (bowel resection or Gastric bypass operation)
  • Advanced cardiac or pulmonary disease
  • patient with thyroid disease & Coagulopathy ( INR >1.4 and platelet count <80,000/ml)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225677


Contacts
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Contact: Revathi Penumatsa, MPH 2164450688 penumar@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Revathi Penumatsa, MPH    216-445-0688    penumar@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Srinivasan Dasarathy, MD The Cleveland Clinic

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Responsible Party: Srinivasan Dasarathy, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03225677     History of Changes
Other Study ID Numbers: 14-1476
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases