TRE in Type 2 Diabetes (See Food Study 3) (SFS3)

April 2, 2026 updated by: University of Minnesota

TRE in Type 2 Diabetes Mellitus (See Food Study 3)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time restricted eating
daily 8 hour eating window
Behavioral: Time restricted eating
Limiting daily eating time to an 8 hour window
Active Comparator: Caloric Restriction
reduction of caloric intake by 15%
Behavioral: Caloric reduction
Cut caloric intake by 15%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycemic Measures- HbA1c (12w)
Time Frame: 12 weeks
Change in hemoglobin A1c
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Change (12w)
Time Frame: 12 weeks
Change in weight from baseline
12 weeks
Weight Change (24w)
Time Frame: 24 weeks
Change in weight from baseline
24 weeks
Change in Glycemic Measures- Insulin (12w)
Time Frame: 12 weeks
Change in fasting insulin
12 weeks
Change in Glycemic Measures- Insulin (24w)
Time Frame: 24 weeks
Change in fasting insulin
24 weeks
Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (24w)
Time Frame: 24 weeks
Change in Homeostatic Model Assessment for Insulin Resistance
24 weeks
Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (12w)
Time Frame: 12 weeks
Change in fasting Homeostatic Model Assessment for Insulin Resistance
12 weeks
Change in Glycemic Measures- HbA1c (24w)
Time Frame: 24 weeks
Change in hemoglobin A1c
24 weeks
Change in Glycemic Measures- Glucose (24w)
Time Frame: 24 weeks
Change in continuous glucose monitoring
24 weeks
Change in Glycemic Measures- Glucose (12w)
Time Frame: 12 weeks
Change in continuous glucose monitoring
12 weeks
Intervention Burden (12w)
Time Frame: 12 weeks
Participant self-report via survey
12 weeks
Intervention Burden (24w)
Time Frame: 24 weeks
Participant self-report via survey
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Lisa Chow, MD, University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2022

Primary Completion (Actual)

December 12, 2025

Study Completion (Actual)

March 23, 2026

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-2022-30316

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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