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

December 2, 2024 updated by: OhioHealth
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Athens, Ohio, United States, 45701
        • OhioHealth Castrop Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time restricted feeding
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
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.
Other Names:
  • Ad libitum feeding

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance
Time Frame: in one week of time restricted feeding
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
Time Frame: in one week of time restricted feeding
change serum triglycerides are measured by a fasting lipid panel
in one week of time restricted feeding
body weight
Time Frame: in one week of time restricted feeding
change in body weight
in one week of time restricted feeding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OhioHealth

Collaborators

Ohio University

Investigators

  • Principal Investigator: Yuanjie Mao, MD, PhD, OhioHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1770741-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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