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COMPLETED
NCT05860413
NA

Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

Summary

To test whether a lifestyle program featuring one of two forms of intermittent fasting (IER or TRE) can feasibly and effectively improve glycemia in patients with type 2 diabetes, and potentially induce diabetes remission.

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

57

Start Date

2023-01-24

Completion Date

2025-05-20

Last Updated

2026-09-29

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Intermittent energy restriction (IER)

During Phase 1 (Weight Loss), participants will follow a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week. On other days, participants do not have a specific kcal goal (non-fasting days). After Phase 1, IER participants will be instructed to follow a VLED 1-2 days per week as needed for weight maintenance.

BEHAVIORAL

Time Restricted Eating (TRE)

Participants will eat within an 8-hour period most days (at least 5 days per week). All foods and beverages containing calories will be restricted to this 8-hour period but calorie-free beverages (coffee, tea, diet soda, etc.) are allowed at any time. TRE participants will follow healthy eating guidelines for weight loss during Phase 1 but not follow a specific kcal prescription or restrict intake thereafter.

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States