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NCT03121404 · ClinicalTrials.gov registry record
Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting
A clinical trial of Cirrhosis, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- 40
- Enrollment target
- 1
- Study location
NCT03121404: Recruiting study of Cirrhosis, sponsored by The Cleveland Clinic.
NCT03121404 is a study of Cirrhosis that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 40 participants, below the 90,408-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03121404, a study of Cirrhosis, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Rectus abdominis muscle biopsy
Study Locations (1)
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-11-14 |
| Est. Completion | 2027-12-31 |
What NCT03121404 shows while recruiting
NCT03121404 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 90,408-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Cirrhosis appearing as the primary indexed condition, and to 1 intervention - of which Rectus abdominis muscle biopsy is the first listed.
NCT03121404 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03121404 about?
NCT03121404 is a clinical study titled "Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting". 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 superf...
What is the current status of trial NCT03121404?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2008-11-14. Estimated completion is 2027-12-31.
What conditions does trial NCT03121404 study?
This clinical trial studies the following conditions: Cirrhosis.
What interventions are being tested in trial NCT03121404?
The interventions under investigation include: Rectus abdominis muscle biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03121404?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03121404 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cirrhosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03121404's enrollment target sits among peer trials
40 28th of 53 higher than 26 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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