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NCT03365531 · ClinicalTrials.gov registry record · NA
RCT of Caloric Restriction vs. Alternate-Day Fasting in Non-Alcoholic Fatty Liver Disease
A NA study, sponsored by University of Florida.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT03365531 is a NA study that was terminated before completion, run by University of Florida. The registered enrollment target is 7 participants.
The verdict
NCT03365531, a NA study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
Non-alcoholic fatty liver disease (NAFLD) in patients with diabetes (T2DM) is increasing in prevalence and can lead to cirrhosis. Lifestyle intervention with caloric restriction (CR) is the cornerstone of treatment but remission is variable. Alternatively, the PI has shown alternate day fasting (ADF) is safe and well tolerated in obese patients and there might be additional beneficial effects. The objective is to combine the expertise of the PI with this novel intervention and the expertise of Dr. Cusi in NAFLD to explore the effects of ADF vs CR in patients with NAFLD and T2DM to test the following hypotheses: H1: In patients with NAFLD and T2DM, the ADF intervention will result in more favorable metabolic changes than CR: H1a: Hepatic triglyceride by MRS will decrease more with ADF than CR (Primary Outcome) and remain lower following a period of free living H1b: There will be greater improvements in glucose homeostasis following ADF vs CR H1c: There will be greater improvement in lipid metabolism following ADF vs CR and changes in ketone metabolism will predict changes in hepatic triglyceride content H2: ADF will have similar safety and tolerability and result in a similar degree of weight loss in participants with NAFLD and DM compared to CR
Interventions
- OTHER Alternate Daily Fasting (ADF)
- OTHER Caloric Restriction (CR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2019-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03365531
The ClinicalTrials.gov registry entry for NCT03365531 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Alternate Daily Fasting (ADF) is the first listed.
NCT03365531 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03365531 about?
NCT03365531 is a clinical study titled "RCT of Caloric Restriction vs. Alternate-Day Fasting in Non-Alcoholic Fatty Liver Disease". Non-alcoholic fatty liver disease (NAFLD) in patients with diabetes (T2DM) is increasing in prevalence and can lead to cirrhosis. Lifestyle intervention with caloric restriction (CR) is the cornerstone of treatment but remission is variable. Alternatively, the PI has shown alternate day fasting (ADF...
What is the current status of trial NCT03365531?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2018-03-01. Estimated completion is 2019-07-01.
What interventions are being tested in trial NCT03365531?
The interventions under investigation include: Alternate Daily Fasting (ADF) (OTHER), Caloric Restriction (CR) (OTHER).
Who is sponsoring clinical trial NCT03365531?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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