TRE in Type 2 Diabetes (See Food Study 3)

NCT05290246 | Completed Results

• 1 other identifier: MED-2022-30316
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Glycemic Measures- HbA1c (12w)

  Change in hemoglobin A1c

  12 weeks

Secondary Outcomes (11)

• Weight Change (12w)

  12 weeks

• Weight Change (24w)

  24 weeks

• Change in Glycemic Measures- Insulin (12w)

  12 weeks

• Change in Glycemic Measures- Insulin (24w)

  24 weeks

• Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (24w)

  24 weeks

Study Arms (2)

Time restricted eating

EXPERIMENTAL

daily 8 hour eating window

Behavioral: Time restricted eating

Caloric Restriction

ACTIVE COMPARATOR

reduction of caloric intake by 15%

Behavioral: Caloric reduction

Interventions

Time restricted eating BEHAVIORAL

Limiting daily eating time to an 8 hour window

Time restricted eating

Caloric reduction BEHAVIORAL

Cut caloric intake by 15%

Caloric Restriction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight/obese adults with metformin-only treated type 2 diabetes
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Intermittent Fasting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Results Point of Contact

• Title: Niki C. Oldenburg, DrPH
• Organization: University of Minnesota

olden019@umn.edu

612-625-8781

Study Officials

• Lisa Chow, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 22, 2022
• Study Start: May 27, 2022
• Primary Completion: December 12, 2025
• Study Completion: March 23, 2026
• Last Updated: April 14, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-04

Locations

US (1)