Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time restricted eating | Experimental | daily 8 hour eating window |
|
| Caloric Restriction | Active Comparator | reduction of caloric intake by 15% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted eating | Behavioral | Limiting daily eating time to an 8 hour window |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycemic Measures- HbA1c (12w) | Change in hemoglobin A1c | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change (12w) | Change in weight from baseline | 12 weeks |
| Weight Change (24w) | Change in weight from baseline | 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Chow, MD | University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Time Restricted Eating | daily 8 hour eating window Time restricted eating: Limiting daily eating time to an 8 hour window |
| FG001 | Caloric Restriction | reduction of caloric intake by 15% Caloric reduction: Cut caloric intake by 15% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Time Restricted Eating | daily 8 hour eating window Time restricted eating: Limiting daily eating time to an 8 hour window |
| BG001 | Caloric Restriction | reduction of caloric intake by 15% Caloric reduction: Cut caloric intake by 15% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycemic Measures- HbA1c (12w) | Change in hemoglobin A1c | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 12 weeks |
|
|
Month 6
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Time Restricted Eating | daily 8 hour eating window Time restricted eating: Limiting daily eating time to an 8 hour window |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Niki C. Oldenburg, DrPH | University of Minnesota | 612-625-8781 | olden019@umn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2025 | Feb 24, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2024 | Feb 24, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Caloric reduction | Behavioral | Cut caloric intake by 15% |
|
| Change in Glycemic Measures- Insulin (12w) | Change in fasting insulin | 12 weeks |
| Change in Glycemic Measures- Insulin (24w) | Change in fasting insulin | 24 weeks |
| Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (24w) | Change in Homeostatic Model Assessment for Insulin Resistance | 24 weeks |
| Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (12w) | Change in fasting Homeostatic Model Assessment for Insulin Resistance | 12 weeks |
| Change in Glycemic Measures- HbA1c (24w) | Change in hemoglobin A1c | 24 weeks |
| Change in Glycemic Measures- Glucose (24w) | Change in continuous glucose monitoring | 24 weeks |
| Change in Glycemic Measures- Glucose (12w) | Change in continuous glucose monitoring | 12 weeks |
| Intervention Burden (12w) | Participant self-report via survey | 12 weeks |
| Intervention Burden (24w) | Participant self-report via survey | 24 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Weight Change (12w) | Change in weight from baseline | Not Posted | 12 weeks | Participants |
| Secondary | Weight Change (24w) | Change in weight from baseline | Not Posted | 24 weeks | Participants |
| Secondary | Change in Glycemic Measures- Insulin (12w) | Change in fasting insulin | Not Posted | 12 weeks | Participants |
| Secondary | Change in Glycemic Measures- Insulin (24w) | Change in fasting insulin | Not Posted | 24 weeks | Participants |
| Secondary | Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (24w) | Change in Homeostatic Model Assessment for Insulin Resistance | Not Posted | 24 weeks | Participants |
| Secondary | Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (12w) | Change in fasting Homeostatic Model Assessment for Insulin Resistance | Not Posted | 12 weeks | Participants |
| Secondary | Change in Glycemic Measures- HbA1c (24w) | Change in hemoglobin A1c | Not Posted | 24 weeks | Participants |
| Secondary | Change in Glycemic Measures- Glucose (24w) | Change in continuous glucose monitoring | Not Posted | 24 weeks | Participants |
| Secondary | Change in Glycemic Measures- Glucose (12w) | Change in continuous glucose monitoring | Not Posted | 12 weeks | Participants |
| Secondary | Intervention Burden (12w) | Participant self-report via survey | Not Posted | 12 weeks | Participants |
| Secondary | Intervention Burden (24w) | Participant self-report via survey | Not Posted | 24 weeks | Participants |
| 0 |
| 32 |
| 0 |
| 32 |
| 4 |
| 32 |
| EG001 | Caloric Restriction | reduction of caloric intake by 15% Caloric reduction: Cut caloric intake by 15% | 0 | 32 | 0 | 32 | 1 | 32 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Loose stool | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pyelonephritis | Renal and urinary disorders | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |