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Behavioral Intervention

Time Restricted Feeding for Type 2 Diabetes

N/A

Recruiting

Led By Yuanjie Mao, MD, PhD

Research Sponsored by OhioHealth

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of type 2 diabetes

Age ≥ 18 years and < 65 years

Must not have

Active infection or malignancy

Unable to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in one week of time restricted feeding

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if reducing the time spent eating each day can improve blood sugar levels for people with uncontrolled type 2 diabetes, potentially allowing them to take less medication.

Who is the study for?

This trial is for adults aged 18-64 with poorly controlled Type 2 diabetes, an A1c level of at least 8.0, and stable on diabetic medications for the past three months. It's not suitable for those with severe hypoglycemia history, advanced organ failure, significant mental impairments, thyroid issues in the last six months, current participation in another study or non-adherence to treatments.

What is being tested?

The study tests if Time-Restricted Feeding can improve blood sugar control in Type 2 diabetes patients using their current or lower doses of antidiabetic drugs over a period of three weeks.

What are the potential side effects?

While not drug-related, potential side effects may include hunger outside allowed eating times and changes in energy levels due to altered meal timing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with type 2 diabetes.

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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active infection or another type of cancer.

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I am unable to understand and agree to the study's procedures and risks.

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I have advanced kidney, liver, lung, or heart failure.

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I have had severe low blood sugar episodes in the last year.

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I do not have dementia or significant mental impairments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in one week of time restricted feeding

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in one week of time restricted feeding

This trial's timeline: 3 weeks for screening, Varies for treatment, and in one week of time restricted feeding for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

estimated hemoglobin A1c levels

mean glucose

Secondary study objectives

Insulin resistance

body weight

serum triglyceride levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Time restricted feedingExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time restricted feeding

2019

Completed Phase 2

~960

0 / 7Eligibility criteria met