TRE in Type 2 Diabetes (See Food Study 3)

Not Applicable

Recruiting

• Conditions: Type2Diabetes
• Interventions: Behavioral: Time restricted eating; Behavioral: Caloric reduction

• Registration Number: NCT05290246
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-22
• Study Start: 2022-05-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-01-01
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time restricted eating	Time restricted eating	daily 8 hour eating window
Caloric Restriction	Caloric reduction	reduction of caloric intake by 15%

Primary Outcome Measures

Name	Time	Method
Change in glycemic measures- HbA1c (12w)	12 weeks	Change in hemoglobin A1c

Secondary Outcome Measures

Name	Time	Method
Change in glycemic measures- Homeostatic Model Assessment for Insulin Resistance (24w)	24 weeks	Change in Homeostatic Model Assessment for Insulin Resistance
Change in glycemic measures- HbA1c (24w)	24 weeks	Change in hemoglobin A1c
Change in glycemic measures- glucose (24w)	24 weeks	Change in continuous glucose monitoring
Weight change (12w)	12 weeks	Change in weight from baseline
Weight change (24w)	24 weeks	Change in weight from baseline
Change in glycemic measures- insulin (12w)	12 weeks	Change in fasting insulin
Change in glycemic measures- insulin (24w)	24 weeks	Change in fasting insulin
Change in glycemic measures- Homeostatic Model Assessment for Insulin Resistance (12w)	12 weeks	Change in fasting Homeostatic Model Assessment for Insulin Resistance
Intervention burden (12w)	12 weeks	Participant self-report via survey
Change in glycemic measures- glucose (12w)	12 weeks	Change in continuous glucose monitoring
Intervention burden (24w)	24 weeks	Participant self-report via survey

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States