Time Restricted Feeding for Type 2 Diabetes

Overseen By Lynn M Petrik, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OhioHealth

Must be taking: Antidiabetics

Disqualifiers: Pregnancy, Thyroid dysfunction, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Yuanjie Mao, MD, PhD

Principal Investigator

OhioHealth

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

OhioHealth Patient

Your A1c level is higher than 8.0 in the last 3 months.

I have been diagnosed with type 2 diabetes.

Exclusion Criteria

I have had thyroid issues in the last 6 months.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ad libitum feeding (Control Phase I)

Participants follow an ad libitum feeding schedule for one week as a control phase

1 week

Time-restricted feeding (Experimental Phase)

Participants follow a time-restricted feeding schedule (feeding between 4 AM - 4 PM) for one week

1 week

Ad libitum feeding (Control Phase II)

Participants return to an ad libitum feeding schedule for one week as a control phase

1 week

Follow-up

Participants are monitored for changes in mean glucose, serum triglyceride levels, insulin resistance, and body weight

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time restricted feeding

Trial Overview 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.

How Is the Trial Designed?

Group I: Time restricted feeding Experimental Treatment 1 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

Who Is Running the Clinical Trial?

OhioHealth

Lead Sponsor

Trials

31

Recruited

5,500+

Ohio University

Collaborator

Trials

73

Recruited

17,800+