Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time restricted feeding
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring intermittent fasting, type 2 diabetes
Eligibility Criteria
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
Sites / Locations
- OhioHealth Castrop Health CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Time restricted feeding
Arm Description
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
Outcomes
Primary Outcome Measures
mean glucose
change in mean glucose
estimated hemoglobin A1c levels
change in estimated hemoglobin A1c levels
Secondary Outcome Measures
Insulin resistance
change in Insulin resistance is represented by the homeostatic model of assessment of insulin resistance
serum triglyceride levels
change serum triglycerides are measured by a fasting lipid panel
body weight
change in body weight
Full Information
NCT ID
NCT05015504
First Posted
August 16, 2021
Last Updated
July 11, 2023
Sponsor
OhioHealth
Collaborators
Ohio University
1. Study Identification
Unique Protocol Identification Number
NCT05015504
Brief Title
Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus
Official Title
Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OhioHealth
Collaborators
Ohio University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
intermittent fasting, type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group self comparison
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Time restricted feeding
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Time restricted feeding
Other Intervention Name(s)
Ad libitum feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
mean glucose
Description
change in mean glucose
Time Frame
in one week of time restricted feeding
Title
estimated hemoglobin A1c levels
Description
change in estimated hemoglobin A1c levels
Time Frame
in one week of time restricted feeding
Secondary Outcome Measure Information:
Title
Insulin resistance
Description
change in Insulin resistance is represented by the homeostatic model of assessment of insulin resistance
Time Frame
in one week of time restricted feeding
Title
serum triglyceride levels
Description
change serum triglycerides are measured by a fasting lipid panel
Time Frame
in one week of time restricted feeding
Title
body weight
Description
change in body weight
Time Frame
in one week of time restricted feeding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanjie Mao, MD, PhD
Phone
740-566-4880
Email
yuanjie.mao@ohiohealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lynn M Petrik, RN
Phone
740-593-2242
Email
petrikl@ohio.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanjie Mao, MD, PhD
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
OhioHealth Castrop Health Center
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanjie Mao, MD
Phone
740-566-4880
Email
yuanjie.mao@ohiohealth.com
First Name & Middle Initial & Last Name & Degree
Lynn Petrik, RN
Phone
740-593-2242
Email
petrikl@ohio.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30683819
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.
Results Reference
background
PubMed Identifier
29754952
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.
Results Reference
background
PubMed Identifier
24993615
Citation
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.
Results Reference
background
Learn more about this trial
Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus
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