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Behavioral Intervention

Time Restricted Feeding for Type 2 Diabetes

Q: How many individuals are currently involved in this research?

Affirmative. Clinicaltrials.gov verifies that this medical experiment, which was published on February 10th 2022, is currently seeking volunteers. A total of 30 participants must be registered from one clinical site.

Q: Is there still room for volunteers in this medical trial?

Affirmative. On clinicaltrials.gov, the details of this trial are listed with a start date on February 10th 2022 and an updated version posted the same day. This medical research is aiming to collect data from 30 patients at one site.

Q: Does this experimental procedure have an age limit for participants?

The age limit for prospective participants is between 18 to 65 years old; hence, 193 and 1105 studies are available specifically designed for those beneath or exceeding this range.

Q: Am I eligible to partake in this clinical investigation?

This clinical trial is seeking 30 participants with <a href="https://www.withpower.com/clinical-trials/type-2-diabetes">type 2 diabetes</a> mellitus who are between 18 and 65 years old.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in one week of time restricted feeding

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with type 2 diabetes.

Select...

I am between 18 and 64 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

estimated hemoglobin A1c levels

mean glucose

Secondary outcome measures

Insulin resistance

body weight

serum triglyceride levels

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

~880

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

OhioHealthLead Sponsor

29 Previous Clinical Trials

2,487 Total Patients Enrolled

Ohio UniversityOTHER

69 Previous Clinical Trials

37,184 Total Patients Enrolled

Yuanjie Mao, MD, PhDPrincipal InvestigatorOhioHealth

Media Library

Time restricted feeding (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05015504 — N/A

Type 2 Diabetes Research Study Groups: Time restricted feeding

Type 2 Diabetes Clinical Trial 2023: Time restricted feeding Highlights & Side Effects. Trial Name: NCT05015504 — N/A

Time restricted feeding (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05015504 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently involved in this research?

"Affirmative. Clinicaltrials.gov verifies that this medical experiment, which was published on February 10th 2022, is currently seeking volunteers. A total of 30 participants must be registered from one clinical site."

Answered by AI

Is there still room for volunteers in this medical trial?

"Affirmative. On clinicaltrials.gov, the details of this trial are listed with a start date on February 10th 2022 and an updated version posted the same day. This medical research is aiming to collect data from 30 patients at one site."

Answered by AI

Does this experimental procedure have an age limit for participants?

"The age limit for prospective participants is between 18 to 65 years old; hence, 193 and 1105 studies are available specifically designed for those beneath or exceeding this range."

Answered by AI