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NCT04861571 · ClinicalTrials.gov registry record · NA
Effect of VLCD on the Reduction of Liver Steatosis and Fibrosis in Subjects With Obesity and NAFLD
A NA study of NAFLD, sponsored by University of Iowa.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04861571 is a NA study of NAFLD that is active but no longer recruiting, run by University of Iowa. The registered enrollment target is 20 participants, below the 164-participant average among 26 other NAFLD trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04861571, a NA study of NAFLD, is active but no longer recruiting, sponsored by University of Iowa.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Non-alcoholic fatty liver disease (NAFLD) is a common complication of obesity which can progress to deadly complications like end-stage liver disease and hepatocellular carcinoma. In the wake of the obesity epidemic, NAFLD is becoming the main etiology of liver transplantation in the US. Currently, there are no FDA approved pharmacological treatments for NAFLD. Weight loss through lifestyle modifications, pharmacotherapy and bariatric surgery can be effective strategies for the management of NAFLD. Even though substantial weight loss and improvement in NAFLD can be achieved with bariatric surgery, only a small proportion of patients with obesity undergo surgery. Very-low calorie diets (VLCD) are replacement meals manufactured to substitute natural foods and limited total intake of 800-960 kcal in divided meals. Very low-calorie diets can produce substantial weight loss of 10% over 2 to 3 months. We hypothesize that VLCD reduce liver steatosis and, fibrosis measured non-invasively with transient elastography. Our main aim is #1 to assess the effect of VLCD on liver fatty infiltration and fibrosis. We also have three exploratory aims exploring novel pathogenic factors that mediate the improvement of NAFLD by VLCD: #2 assess the effect of VLCD on micro RNAs (miRs) associated with pathophysiology of NAFLD: #3 assess the effect of VLCD on changes of salivary and fecal microbiome in the setting of NAFLD: #4 to determine the effect of VLCD on platelet function. This pilot project will produce preliminary data for the development of a larger grant application to study the efficacy of VLCD in the management of NAFLD. Furthermore, it will potentially identify factors that mediate improvement of NAFLD after VLCD. We will treat 10 subjects with obesity and NAFLD for 8 weeks with VLCD or lower calorie diet (control group) and obtain transient elastography before and after the interventions along with other measurements of interest. Our project may have significant impact by esta
Conditions Studied
Interventions
- OTHER Control Arm
- DIETARY_SUPPLEMENT Dietary intervention with very low calorie diet (VLCD)
Study Locations (1)
Iowa
- University of Iowa Health Care - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2026-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04861571
The ClinicalTrials.gov registry entry for NCT04861571 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 164-participant average among 26 other NAFLD trials with a reported enrollment target (88% lower). The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with NAFLD appearing as the primary indexed condition, and to 2 interventions - of which Control Arm is the first listed.
NCT04861571 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT04861571 about?
NCT04861571 is a clinical study titled "Effect of VLCD on the Reduction of Liver Steatosis and Fibrosis in Subjects With Obesity and NAFLD". Non-alcoholic fatty liver disease (NAFLD) is a common complication of obesity which can progress to deadly complications like end-stage liver disease and hepatocellular carcinoma. In the wake of the obesity epidemic, NAFLD is becoming the main etiology of liver transplantation in the US. Currently, ...
What is the current status of trial NCT04861571?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2023-10-01. Estimated completion is 2026-12.
What conditions does trial NCT04861571 study?
This clinical trial studies the following conditions: NAFLD.
What interventions are being tested in trial NCT04861571?
The interventions under investigation include: Control Arm (OTHER), Dietary intervention with very low calorie diet (VLCD) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04861571?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04861571 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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