Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus

University of Kansas

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Time Restricted Eating (TRE); Behavioral: Intermittent energy restriction (IER)

Study type: Interventional

Funder types: Other

Identifiers

NCT05860413

STUDY00149127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with type 2 diabetes in the past 10 years.
2. Age 21-65 years
3. BMI of 25 - 45 kg/m2
4. HbA1c of 6.7-9.5%, or those with A1c of <6.7% on glucose-lowering medications
5. Ability to participate in a graduated physical activity program
6. Clearance from study physician.

Exclusion criteria

1. Inability to attend health education meetings.
2. Weight change of >=5% in the previous 3 months.
3. Addition of new antihyperglycemic or weight-reducing medication in the previous 2 months.
4. 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.
5. Untreated depression or anxiety, or increase in associated medications in the previous 3 months.
6. Current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program.
7. Pregnancy or lactation within the previous six months
8. Weight of >450 lbs
9. Currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups

Intermittent energy restriction (IER)

Experimental group

Description:

Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week

Treatment:

Behavioral: Intermittent energy restriction (IER)

Time-restricted eating (TRE)

Experimental group

Description:

Intermittent fasting using an 8-hour eating period.

Treatment:

Behavioral: Time Restricted Eating (TRE)