Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intermittent energy restriction (IER) Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week |
Behavioral: Intermittent energy restriction (IER)
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.
|
| Experimental: Time-restricted eating (TRE) Intermittent fasting using an 8-hour eating period. |
Behavioral: Time Restricted Eating (TRE)
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.
|
Outcome Measures
Primary Outcome Measures
- Retention [52 weeks]
Feasibility of IER and TRE over one year assessed by retention (# completed / # enrolled) and attendance (# classes attended / # classes offered).
- Adherence to diet protocols [Weekly from baseline to 52 weeks]
Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (# weeks adhered / # study weeks).
Secondary Outcome Measures
- HbA1c [Change from baseline to 24 weeks]
Estimate the effects for both IER and TRE on long-term glycemic control assessed via HbA1c
- Oral Glucose Tolerance Test [Change from baseline to 24 weeks]
Estimate the effects for both IER and TRE on fasting and 3 hr glucose result.
- Isulin resistance [Change from baseline to 24 weeks]
Estimate the effects for both IER and TRE on insulin resistance estimated by the oral minimal model during a mixed meal tolerance test
- Insulin sensitivity [Change from baseline to 24 weeks]
Estimate the effects for both IER and TRE on insulin sensitivity estimated by the oral minimal model during a mixed meal tolerance test
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with type 2 diabetes in the past 10 years.
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Age 21-65 years
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BMI of 25 - 45 kg/m2
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HbA1c of 6.7-9.5%, or those with A1c of <6.7% on glucose-lowering medications
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Ability to participate in a graduated physical activity program
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Clearance from study physician.
Exclusion Criteria:
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Inability to attend health education meetings.
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Weight change of >=5% in the previous 3 months.
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Addition of new antihyperglycemic or weight-reducing medication in the previous 2 months.
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Serious medical risk such as ongoing treatment for cancer, uncontrolled hypertension, recent cardiac event, or other medical condition presenting acute risk of participation in a lifestyle change program.
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Untreated depression or anxiety, or increase in associated medications in the previous 3 months.
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Current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program.
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Pregnancy or lactation within the previous six months
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Weight of >450 lbs
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Currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
Sponsors and Collaborators
- University of Kansas Medical Center
- American Diabetes Association
- National Institutes of Health (NIH)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00149127