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In this 3-week interventional study, the investigators hypothesize that therapeutic Time-Restricted Feeding in patients with poorly controlled Type 2 diabetes mellitus (T2DM) can improve their mean glucose or estimated glycated hemoglobin levels with the same dose, or even reduced dose, of antidiabetics.
Time-restricted feeding (TRF) has recently gained popularity as a means of reducing body weight and improving glycemia. A recent clinical trial in men who had prediabetes showed that TRF for five weeks significantly reduced fasting insulin concentration and improved the derived oral glucose tolerance test ( OGTT) indexes of beta-cell responsiveness and insulin resistance. However, the effects of TRF have not been studied in patients with poorly controlled Type 2 diabetes mellitus (T2DM). In this 3-week interventional self-controlled clinical trial, the investigators hypothesize that TRF in patients with poorly-controlled T2DM can improve their mean glucose with the same dose/reduced dose of antidiabetics. Potential study subjects will be identified from Endocrinology clinic patients with a diagnosis of poorly controlled type 2 DM (A1c \>= 8.0 in the 3 months before enrollment) based on inclusion and exclusion criteria. All study subjects will be in the ad libitum feeding phase for one week, and then will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for the second week. For the third and final week, patients will be returned to the ad libitum feeding phase. The first and third weeks will serve as the control phases, and the second week will be the experimental phase. The mean glucose, serum triglyceride levels, insulin resistance, and body weights will be compared between the two phases. Results of this clinical study may demonstrate a low-cost and practical way of diabetic control.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
OhioHealth Castrop Health Center
Athens, Ohio, United States
Start Date
February 10, 2022
Primary Completion Date
July 1, 2025
Completion Date
September 1, 2025
Last Updated
December 4, 2024
30
ESTIMATED participants
Time restricted feeding
BEHAVIORAL
Lead Sponsor
OhioHealth
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06671587