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NCT01324414 · ClinicalTrials.gov registry record
Impact of Muscle Insulin Resistance on the Pathogenesis of Non Alcoholic Steatohepatitis
A clinical trial of Non Alcoholic Fatty Liver Diseases (NAFLD), sponsored by Mayo Clinic.
- Completed
- Registry status
- 90
- Enrollment target
- 1
- Study location
NCT01324414 is a study of Non Alcoholic Fatty Liver Diseases (NAFLD) that has completed, run by Mayo Clinic. The registered enrollment target is 90 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01324414, a study of Non Alcoholic Fatty Liver Diseases (NAFLD), has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The incidence of Non alcoholic fatty liver disease (NAFLD) continues to increase, and prevalence estimates for NAFLD range from 17-33%, making it is the most common cause of chronic liver disease in North America. It is associated with increased cardiovascular morbidity as well as progression to cirrhosis is a subset of patients. There is currently no approved treatment for NAFLD. A key barrier to the development of effective therapies is a lack of consensus on the criteria for diagnosis and endpoints for studies evaluating diagnostic markers, prognosis and therapeutic modalities. NAFLD encompasses an entire pathological spectrum of disease, from relatively benign accumulation of lipid (steatosis) to progressive non alcoholic steatohepatitis (NASH) associated with inflammation, fibrosis, and necrosis. It has been estimated that 20-30% of patients with NAFLD will exhibit biochemical and histological changes characteristic of NASH, and 15-20% of those patients will progress to have cirrhosis. NASH remains an important phenotypic state, because this sub-group of patients is deemed at high-risk for developing progressive disease resulting in cirrhosis, liver failure requiring transplantation, or death. Although NAFLD has not to date been included as a component of the metabolic syndrome, there is increasing evidence that NAFLD frequently accompanies the development of insulin resistance and therefore may be an indicator or predictor of future cardiometabolic risk. Moreover, recent findings in skeletal muscle of experimental insulin resistance (lipid infusion) as well as naturally occurring obese and type 2 diabetic, insulin resistant patients show that skeletal muscle inflammation leads to a pattern of extracellular matrix, structural, and remodeling abnormalities that closely resemble the TGFb, connective tissue growth factor (CTGF) mediated fibrotic response that differentiates simple steatotic liver from NASH. This suggests there may be a common underlying mechanis
Conditions Studied
Study Locations (1)
Arizona
- Mayo Clinic - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2010-12 |
| Est. Completion | 2016-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01324414
The ClinicalTrials.gov registry entry for NCT01324414 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non Alcoholic Fatty Liver Diseases (NAFLD) appearing as the primary indexed condition, and to 0 interventions.
NCT01324414 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT01324414 about?
NCT01324414 is a clinical study titled "Impact of Muscle Insulin Resistance on the Pathogenesis of Non Alcoholic Steatohepatitis". The incidence of Non alcoholic fatty liver disease (NAFLD) continues to increase, and prevalence estimates for NAFLD range from 17-33%, making it is the most common cause of chronic liver disease in North America. It is associated with increased cardiovascular morbidity as well as progression to cir...
What is the current status of trial NCT01324414?
This trial is currently completed. The enrollment target is 90 participants. The study started on 2010-12. Estimated completion is 2016-01.
What conditions does trial NCT01324414 study?
This clinical trial studies the following conditions: Non Alcoholic Fatty Liver Diseases (NAFLD).
Who is sponsoring clinical trial NCT01324414?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01324414 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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