Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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 |
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention
Time Frame: 52 weeks
|
Feasibility of IER and TRE over one year assessed by participant retention (% of participants completed). |
52 weeks
|
|
Adherence to Diet Protocols
Time Frame: Weekly from baseline to 52 weeks
|
Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (% of weeks adhered) |
Weekly from baseline to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c
Time Frame: Change from baseline to 24 weeks
|
Change in glycemic control assessed via HbA1c (%) |
Change from baseline to 24 weeks
|
|
Postprandial Glucose
Time Frame: Change from baseline to 24 weeks
|
Estimate the effects for both IER and TRE on fasting and mean glucose during a 3 hr mixed meal tolerance test. |
Change from baseline to 24 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00149127
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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