Type 2 Diabetes
Conditions
Keywords
intermittent fasting, type 2 diabetes
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.
Interventions
BEHAVIORALTime 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.
Sponsors
OhioHealth
Ohio University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group self comparison
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean glucose | in one week of time restricted feeding | change in mean glucose |
| estimated hemoglobin A1c levels | in one week of time restricted feeding | change in estimated hemoglobin A1c levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance | in one week of time restricted feeding | change in Insulin resistance is represented by the homeostatic model of assessment of insulin resistance |
| serum triglyceride levels | in one week of time restricted feeding | change serum triglycerides are measured by a fasting lipid panel |
| body weight | in one week of time restricted feeding | change in body weight |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYuanjie Mao, MD, PhD
OhioHealth
Outcome results
None listed