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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
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To test whether a lifestyle program featuring one of two forms of intermittent fasting (IER or TRE) can feasibly and effectively improve glycemia in patients with type 2 diabetes, and potentially induce diabetes remission.
Intermittent energy restriction (IER) and time-restricted eating (TRE) are two distinct forms of intermittent fasting which have yet to be compared for the treatment of type 2 diabetes. Investigators will test whether a comprehensive, intensive lifestyle program featuring each of these intermittent fasting approaches is feasible and effective for improving glycemic control in patients diagnosed with type 2 diabetes within the past 10 years. Both interventions will be delivered over one year in three phases: (1) a 12-week weight loss program featuring weekly group meetings, (2) a 12-week weight maintenance program featuring biweekly group meetings, and (3) a 6-month low-contact follow up period featuring monthly check-ins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent energy restriction (IER) | Experimental | Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week |
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| Time-restricted eating (TRE) | Experimental | Intermittent fasting using an 8-hour eating period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent energy restriction (IER) | Behavioral | During Phase 1 (Weight Loss), participants will follow a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week. On other days, participants do not have a specific kcal goal (non-fasting days). After Phase 1, IER participants will be instructed to follow a VLED 1-2 days per week as needed for weight maintenance. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Feasibility of IER and TRE over one year assessed by retention (# completed / # enrolled) and attendance (# classes attended / # classes offered). | 52 weeks |
| Adherence to diet protocols | Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (# weeks adhered / # study weeks). | Weekly from baseline to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Estimate the effects for both IER and TRE on long-term glycemic control assessed via HbA1c | Change from baseline to 24 weeks |
| Oral Glucose Tolerance Test | Estimate the effects for both IER and TRE on fasting and 3 hr glucose result. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 20, 2026 | |
| Reset | Jun 17, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2026 | Jun 17, 2026 | |||
| Jul 9, 2026 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Time Restricted Eating (TRE) | Behavioral | Participants will eat within an 8-hour period most days (at least 5 days per week). All foods and beverages containing calories will be restricted to this 8-hour period but calorie-free beverages (coffee, tea, diet soda, etc.) are allowed at any time. TRE participants will follow healthy eating guidelines for weight loss during Phase 1 but not follow a specific kcal prescription or restrict intake thereafter. |
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| Change from baseline to 24 weeks |
| Isulin resistance | Estimate the effects for both IER and TRE on insulin resistance estimated by the oral minimal model during a mixed meal tolerance test | Change from baseline to 24 weeks |
| Insulin sensitivity | Estimate the effects for both IER and TRE on insulin sensitivity estimated by the oral minimal model during a mixed meal tolerance test | Change from baseline to 24 weeks |
| D004700 | Endocrine System Diseases |