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NCT Number: NCT05860413

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Retention

    Time frame: 52 weeks

    Feasibility of IER and TRE over one year assessed by retention (# completed / # enrolled) and attendance (# classes attended / # classes offered).

  2. 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 (# weeks adhered / # study weeks).

Secondary outcomes

  1. HbA1c

    Time frame: Change from baseline to 24 weeks

    Estimate the effects for both IER and TRE on long-term glycemic control assessed via HbA1c

  2. Oral Glucose Tolerance Test

    Time frame: Change from baseline to 24 weeks

    Estimate the effects for both IER and TRE on fasting and 3 hr glucose result.

  3. Isulin resistance

    Time frame: Change from baseline to 24 weeks

    Estimate the effects for both IER and TRE on insulin resistance estimated by the oral minimal model during a mixed meal tolerance test

  4. Insulin sensitivity

    Time frame: Change from baseline to 24 weeks

    Estimate the effects for both IER and TRE on insulin sensitivity estimated by the oral minimal model during a mixed meal tolerance test

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • American Diabetes Association

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 16, 2023
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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