Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus

Purpose

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

  • Type 2 Diabetes

Eligibility

Eligible Ages
Between 21 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Felicia Steger, PhD
913-735-5411
fsteger@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Felicia Steger, PhD
913-735-5411
fsteger@kumc.edu

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.