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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Brad Yentzer or Abdisa Taddese
seefoodstudy@umn.edu
612-419-5738
Time Frame
Start Date: 2022-05-27
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 60
Treatments
Experimental: Time restricted eating
daily 8 hour eating window
Active_comparator: Caloric Restriction
reduction of caloric intake by 15%
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov