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TRE in Type 2 Diabetes (See Food Study 3)

Not Applicable
Recruiting
Conditions
Type2Diabetes
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

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
Primary Outcome Measures
NameTimeMethod
Change in glycemic measures- HbA1c (12w)12 weeks

Change in hemoglobin A1c

Secondary Outcome Measures
NameTimeMethod
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

Change in glycemic measures- glucose (12w)12 weeks

Change in continuous glucose monitoring

Intervention burden (24w)24 weeks

Participant self-report via survey

Intervention burden (12w)12 weeks

Participant self-report via survey

Trial Locations

Locations (1)

University of Minnesota

🇺🇸

Minneapolis, Minnesota, United States

University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Brad Yentzer or Abdisa Taddese
Contact
612-419-5738
seefoodstudy@umn.edu

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