Clinical trial NCT05015504: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: intermittent fasting
type 2 diabetes
Lead sponsor: OhioHealth
Sponsor class: OTHER
Collaborators: name: Ohio University
First posted: 2021-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group self comparison
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: mean glucose
timeFrame: in one week of time restricted feeding
measure: estimated hemoglobin A1c levels
timeFrame: in one week of time restricted feeding
Secondary outcomes:
measure: Insulin resistance
timeFrame: in one week of time restricted feeding
measure: serum triglyceride levels
timeFrame: in one week of time restricted feeding
measure: body weight
timeFrame: in one week of time restricted feeding
Other outcomes:
Locations:
city: Athens
country: United States
facility: OhioHealth Castrop Health Center
state: Ohio
Study officials:
affiliation: OhioHealth
name: Yuanjie Mao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.