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TRE in Type 2 Diabetes (See Food Study 3)

NCT05290246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-04-14

Study results available
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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.

Conditions

  • Type2Diabetes

Interventions

BEHAVIORAL

Time restricted eating

Limiting daily eating time to an 8 hour window

BEHAVIORAL

Caloric reduction

Cut caloric intake by 15%

Sponsors & Collaborators

Principal Investigators

  • Lisa Chow, MD · University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2025-12-12
Completion
2026-03-23

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05290246 on ClinicalTrials.gov