Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-02 @ 6:05 AM
Study NCT ID:
NCT05015504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-04
First Post:
2021-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus
Sponsor:
OhioHealth
Organization:
Study Overview
Official Title:
Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: