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TRE in Type 2 Diabetes (See Food Study 3)

NCT ID: NCT05290246

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type2Diabetes

Keywords

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Type 2 diabetes diet intervention intermittent fasting caloric restriction time restricted eating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Time restricted eating

daily 8 hour eating window

Group Type EXPERIMENTAL

Time restricted eating

Intervention Type BEHAVIORAL

Limiting daily eating time to an 8 hour window

Caloric Restriction

reduction of caloric intake by 15%

Group Type ACTIVE_COMPARATOR

Caloric reduction

Intervention Type BEHAVIORAL

Cut caloric intake by 15%

Interventions

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Time restricted eating

Limiting daily eating time to an 8 hour window

Intervention Type BEHAVIORAL

Caloric reduction

Cut caloric intake by 15%

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Chow, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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MED-2022-30316

Identifier Type: -

Identifier Source: org_study_id