N/A
N=64
TRE in Type 2 Diabetes (See Food Study 3)
Type2Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05290246 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Change in Glycemic Measures- HbA1c (12w) — -0.22; -0.25 percentage of glycated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Time restricted eating (Behavioral); Caloric reduction (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Dec 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycemic Measures- HbA1c (12w) |
-0.22; -0.25 | — |
| SECONDARY Weight Change (12w) |
— | — |
| SECONDARY Weight Change (24w) |
— | — |
| SECONDARY Change in Glycemic Measures- Insulin (12w) |
— | — |
| SECONDARY Change in Glycemic Measures- Insulin (24w) |
— | — |
| SECONDARY Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (24w) |
— | — |
| SECONDARY Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (12w) |
— | — |
| SECONDARY Change in Glycemic Measures- HbA1c (24w) |
— | — |
| SECONDARY Change in Glycemic Measures- Glucose (24w) |
— | — |
| SECONDARY Change in Glycemic Measures- Glucose (12w) |
— | — |
| SECONDARY Intervention Burden (12w) |
— | — |
| SECONDARY Intervention Burden (24w) |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Overweight/obese adults with metformin-only treated type 2 diabetes
- 18-65 years old
- BMI:25-45 kg/m2
- HbA1c: 6.5-8.5%
- Self-reported weight must be stable [±5 pounds] for at least 3 months prior to the study
- Owns a smartphone.
Exclusion Criteria
- Active or anticipated pregnancy during the study
- type 2 diabetes treated with medications other than metformin
- presence of eating disorders as noted by screening survey.
Data sourced from ClinicalTrials.gov (NCT05290246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.