Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus

NCT05860413 | Completed DMC

• 1 other identifier: STUDY00149127
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• HbA1c

  Change from baseline to 24 weeks

• Oral Glucose Tolerance Test

  Change from baseline to 24 weeks

• Isulin resistance

  Change from baseline to 24 weeks

• Insulin sensitivity

  Change from baseline to 24 weeks

Study Arms (2)

Intermittent energy restriction (IER)

EXPERIMENTAL

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

Behavioral: Intermittent energy restriction (IER)

Time-restricted eating (TRE)

EXPERIMENTAL

Intermittent fasting using an 8-hour eating period.

Behavioral: Time Restricted Eating (TRE)

Interventions

Intermittent energy restriction (IER) BEHAVIORAL

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.

Intermittent energy restriction (IER)

Time Restricted Eating (TRE) BEHAVIORAL

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.

Time-restricted eating (TRE)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• American Diabetes Association: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: May 16, 2023
• Study Start: January 24, 2023
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)