Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. This study proposes a 24 week feasibility study to test if TRE is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients \[BMI:25-45 kg/m2\] with metformin-only treated Type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Limiting daily eating time to an 8 hour window
Cut caloric intake by 15%
University of Minnesota
Minneapolis, Minnesota, United States
Change in Glycemic Measures- HbA1c (12w)
Change in hemoglobin A1c
Time frame: 12 weeks
Weight Change (12w)
Change in weight from baseline
Time frame: 12 weeks
Weight Change (24w)
Change in weight from baseline
Time frame: 24 weeks
Change in Glycemic Measures- Insulin (12w)
Change in fasting insulin
Time frame: 12 weeks
Change in Glycemic Measures- Insulin (24w)
Change in fasting insulin
Time frame: 24 weeks
Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (24w)
Change in Homeostatic Model Assessment for Insulin Resistance
Time frame: 24 weeks
Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (12w)
Change in fasting Homeostatic Model Assessment for Insulin Resistance
Time frame: 12 weeks
Change in Glycemic Measures- HbA1c (24w)
Change in hemoglobin A1c
Time frame: 24 weeks
Change in Glycemic Measures- Glucose (24w)
Change in continuous glucose monitoring
Time frame: 24 weeks
Change in Glycemic Measures- Glucose (12w)
Change in continuous glucose monitoring
Time frame: 12 weeks
Intervention Burden (12w)
Participant self-report via survey
Time frame: 12 weeks
Intervention Burden (24w)
Participant self-report via survey
Time frame: 24 weeks
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