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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.