Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes
- Interventions
- Behavioral: Time Restricted Eating (TRE)Behavioral: Intermittent energy restriction (IER)
- Registration Number
- NCT05860413
- Lead Sponsor
- University of Kansas Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 57
- Diagnosed with type 2 diabetes in the past 10 years.
- Age 21-65 years
- BMI of 25 - 45 kg/m2
- HbA1c of 6.7-9.5%, or those with A1c of <6.7% on glucose-lowering medications
- Ability to participate in a graduated physical activity program
- Clearance from study physician.
- Inability to attend health education meetings.
- Weight change of >=5% in the previous 3 months.
- Addition of new antihyperglycemic or weight-reducing medication in the previous 2 months.
- 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.
- Untreated depression or anxiety, or increase in associated medications in the previous 3 months.
- Current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program.
- Pregnancy or lactation within the previous six months
- Weight of >450 lbs
- Currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Time-restricted eating (TRE) Time Restricted Eating (TRE) Intermittent fasting using an 8-hour eating period. Intermittent energy restriction (IER) Intermittent energy restriction (IER) Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week
- Primary Outcome Measures
Name Time Method 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).
Retention 52 weeks Feasibility of IER and TRE over one year assessed by retention (# completed / # enrolled) and attendance (# classes attended / # classes offered).
- Secondary Outcome Measures
Name Time Method HbA1c Change from baseline to 24 weeks Estimate the effects for both IER and TRE on long-term glycemic control assessed via HbA1c
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
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
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States