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: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Intermittent energy restriction (IER); Behavioral: Time Restricted Eating (TRE)

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: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	Feasibility of IER and TRE over one year assessed by retention (# completed / # enrolled) and attendance (# classes attended / # classes offered).	52 weeks
Adherence to diet protocols	Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (# weeks adhered / # study weeks).	Weekly from baseline to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Estimate the effects for both IER and TRE on long-term glycemic control assessed via HbA1c	Change from baseline to 24 weeks
Oral Glucose Tolerance Test	Estimate the effects for both IER and TRE on fasting and 3 hr glucose result.	Change from baseline to 24 weeks
Isulin resistance	Estimate the effects for both IER and TRE on insulin resistance estimated by the oral minimal model during a mixed meal tolerance test	Change from baseline to 24 weeks
Insulin sensitivity	Estimate the effects for both IER and TRE on insulin sensitivity estimated by the oral minimal model during a mixed meal tolerance test	Change from baseline to 24 weeks

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: American Diabetes Association

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Actual): May 20, 2025
• Study Completion (Actual): May 20, 2025

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY00149127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No