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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015504
• Other study ID #: 1770741-4
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: September 2025

Study information

• Verified date: July 2023
• Source: OhioHealth
• Contact: Yuanjie Mao, MD, PhD
• Phone: 740-566-4880
• Email: yuanjie.mao[@]ohiohealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	OhioHealth Castrop Health Center	Athens	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
OhioHealth	Ohio University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barnosky AR, Hoddy KK, Unterman TG, Varady KA. Intermittent fasting vs daily calorie restriction for type 2 diabetes prevention: a review of human findings. Transl Res. 2014 Oct;164(4):302-11. doi: 10.1016/j.trsl.2014.05.013. Epub 2014 Jun 12. — View Citation

Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10. — View Citation

Zubrzycki A, Cierpka-Kmiec K, Kmiec Z, Wronska A. The role of low-calorie diets and intermittent fasting in the treatment of obesity and type-2 diabetes. J Physiol Pharmacol. 2018 Oct;69(5). doi: 10.26402/jpp.2018.5.02. Epub 2019 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean glucose	change in mean glucose	in one week of time restricted feeding
Primary	estimated hemoglobin A1c levels	change in estimated hemoglobin A1c levels	in one week of time restricted feeding
Secondary	Insulin resistance	change in Insulin resistance is represented by the homeostatic model of assessment of insulin resistance	in one week of time restricted feeding
Secondary	serum triglyceride levels	change serum triglycerides are measured by a fasting lipid panel	in one week of time restricted feeding
Secondary	body weight	change in body weight	in one week of time restricted feeding