Type2Diabetes
Conditions
Keywords
Type 2 diabetes, diet intervention, intermittent fasting, caloric restriction, time restricted eating
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.
Interventions
BEHAVIORALTime restricted eating
Limiting daily eating time to an 8 hour window
BEHAVIORALCaloric reduction
Cut caloric intake by 15%
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycemic Measures- HbA1c (12w) | 12 weeks | Change in hemoglobin A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (24w) | 24 weeks | Change in Homeostatic Model Assessment for Insulin Resistance |
| 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- HbA1c (24w) | 24 weeks | Change in hemoglobin A1c |
| Change in Glycemic Measures- Glucose (24w) | 24 weeks | Change in continuous glucose monitoring |
| Change in Glycemic Measures- Glucose (12w) | 12 weeks | Change in continuous glucose monitoring |
| Intervention Burden (12w) | 12 weeks | Participant self-report via survey |
| Intervention Burden (24w) | 24 weeks | Participant self-report via survey |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLisa Chow, MD
University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 7.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 4 / 32 | 1 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
None listed