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

NCT05015504 | Active Not Recruiting

• 1 other identifier: 1770741-4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

intermittent fasting; type 2 diabetes

Outcome Measures

Primary Outcomes (2)

• mean glucose

  change in mean glucose

  in one week of time restricted feeding

• estimated hemoglobin A1c levels

  change in estimated hemoglobin A1c levels

  in one week of time restricted feeding

Secondary Outcomes (3)

• Insulin resistance

  in one week of time restricted feeding

• serum triglyceride levels

  in one week of time restricted feeding

• body weight

  in one week of time restricted feeding

Study Arms (1)

Time restricted feeding

EXPERIMENTAL

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

Interventions

Time restricted feeding BEHAVIORAL

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.

Also known as: Ad libitum feeding

Time restricted feeding

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OhioHealth: lead
• Ohio University: collaborator

Study Sites (1)

OhioHealth Castrop Health Center

Athens, Ohio, 45701, United States

Location

Related Publications (3)

• 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.

  PMID: 30683819 BACKGROUND

• 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.

  PMID: 29754952 BACKGROUND

• 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.

  PMID: 24993615 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Intermittent Fasting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Yuanjie Mao, MD, PhD

  OhioHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group self comparison

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: February 10, 2022
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)