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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Time restricted feeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group self comparison
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time restricted feeding<br>The study will consist of three phases. In phase I all study subjects will be in the ad libitum feeding phase for one week followed by Phase II. In Phase II the subjects will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for one week. For phase III (final week), patients will be returned to an ad libitum feeding. The first and third phases will serve as control phases, and the second phase will be the experimental phase | Behavioral: Time restricted feeding<br>* In Phase II the study subjects will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for one week.<br>* Other names: Ad libitum feeding;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean glucose | change in mean glucose | in one week of time restricted feeding | 
| estimated hemoglobin A1c levels | change in estimated hemoglobin A1c levels | in one week of time restricted feeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | change in Insulin resistance is represented by the homeostatic model of assessment of insulin resistance | in one week of time restricted feeding | 
| serum triglyceride levels | change serum triglycerides are measured by a fasting lipid panel | in one week of time restricted feeding | 
| body weight | change in body weight | in one week of time restricted feeding | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intermittent fasting, type 2 diabetes