Skip to main content
OpenTrials
Completed

NCT Number: NCT05290246

TRE in Type 2 Diabetes (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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type2diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Intermittent Fasting Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time restricted eating

Behavioral

Limiting daily eating time to an 8 hour window

Caloric reduction

Behavioral

Cut caloric intake by 15%

Primary outcomes

  1. Change in Glycemic Measures- HbA1c (12w)

    Time frame: 12 weeks

    Change in hemoglobin A1c

Secondary outcomes

  1. Weight Change (12w)

    Time frame: 12 weeks

    Change in weight from baseline

  2. Weight Change (24w)

    Time frame: 24 weeks

    Change in weight from baseline

  3. Change in Glycemic Measures- Insulin (12w)

    Time frame: 12 weeks

    Change in fasting insulin

  4. Change in Glycemic Measures- Insulin (24w)

    Time frame: 24 weeks

    Change in fasting insulin

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

    Time frame: 24 weeks

    Change in Homeostatic Model Assessment for Insulin Resistance

  6. Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (12w)

    Time frame: 12 weeks

    Change in fasting Homeostatic Model Assessment for Insulin Resistance

  7. Change in Glycemic Measures- HbA1c (24w)

    Time frame: 24 weeks

    Change in hemoglobin A1c

  8. Change in Glycemic Measures- Glucose (24w)

    Time frame: 24 weeks

    Change in continuous glucose monitoring

  9. Change in Glycemic Measures- Glucose (12w)

    Time frame: 12 weeks

    Change in continuous glucose monitoring

  10. Intervention Burden (12w)

    Time frame: 12 weeks

    Participant self-report via survey

  11. Intervention Burden (24w)

    Time frame: 24 weeks

    Participant self-report via survey

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: SFS3

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 22, 2022
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.