Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus

  • STATUS
    Recruiting
  • End date
    Jul 22, 2024
  • participants needed
    30
  • sponsor
    OhioHealth
Updated on 22 March 2022
fasting
type 2 diabetes mellitus
antidiabetic agents

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.

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.

Details
Condition Type 2 Diabetes
Treatment Time restricted feeding
Clinical Study IdentifierNCT05015504
SponsorOhioHealth
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years and < 65 years
With the diagnosis of type 2 diabetes
A1c >= 8.0 on the most recent test in the 3 months before enrollment
Have been on stable antidiabetics in the 3 months before enrollment
OhioHealth Patient

Exclusion Criteria

Pregnant or breastfeeding patients
Severe hypoglycemic episodes (defined as having low blood glucose levels that requires assistance from another person to treat) in the past 12 months
Unable to give informed consent
Currently enrolled in another therapeutic study
Thyroid dysfunction, as defined by abnormal thyroid function test results within the past 6 months
Advanced stage of renal (stage 4 or above) or hepatic (cirrhosis) or respiratory (needs oxygen) or heart failure (NYHA class 3 or above)
Active infection or malignancy
Dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
Clinician-reported history of patient non-adherence
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