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RCT of Caloric Restriction vs. Alternate-Day Fasting in Non-Alcoholic Fatty Liver Disease

NCT03365531 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-09-23

No results posted yet for this 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

Conditions

  • NAFLD
  • Obesity
  • Diabetes Mellitus, Type 2

Interventions

OTHER

Alternate Daily Fasting (ADF)

See ADF arm for details

OTHER

Caloric Restriction (CR)

See CR arm for details

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • William T Donahoo, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-07-01
Completion
2019-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03365531 on ClinicalTrials.gov