TRE in Type 2 Diabetes (See Food Study 3) (SFS3)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
115 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Brad Yentzer or Abdisa Taddese
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal