Type 2 DiabetesNCT05860413

Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus

A study testing Intermittent energy restriction (IER) and Time Restricted Eating (TRE) in people with Type 2 Diabetes, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Intermittent energy restriction (IER) and Time Restricted Eating (TRE)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteUnited States
Study dates: 24 Jan 2023to 20 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

Read the 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.

Conditions: Type 2 Diabetes
Being tested: Intermittent energy restriction (IER), Time Restricted Eating (TRE)
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intermittent energy restriction (IER)Behavioural
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)Behavioural
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.

Study groups in NCT05860413
Study group	Role	What they receive
Intermittent energy restriction (IER)	Experimental	Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week Receives: Behavioral: Intermittent energy restriction (IER)
Time-restricted eating (TRE)	Experimental	Intermittent fasting using an 8-hour eating period. Receives: Behavioral: Time Restricted Eating (TRE)

What is being measured

The primary outcome is the main question the study is designed to answer.

Retention
Feasibility of IER and TRE over one year assessed by participant retention (% of participants completed).
Measured: 52 weeks
Adherence to Diet Protocols
Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (% of weeks adhered)
Measured: Weekly from baseline to 52 weeks

Secondary outcomes (2)

HbA1c
Change in glycemic control assessed via HbA1c (%)
Measured: Change from baseline to 24 weeks
Postprandial Glucose
Estimate the effects for both IER and TRE on fasting and mean glucose during a 3 hr mixed meal tolerance test.
Measured: Change from baseline to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 202320 May 2025

First posted16 May 2023
Study start24 Jan 2023
Primary completion20 May 2025
Study completion20 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05860413
Sponsor's protocol ID: STUDY00149127
Status last verified: May 2026
First submitted: 23 Feb 2023
Last updated: 29 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT05860413
Acronym / sponsor ID: STUDY00149127
Conditions: Type 2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Collaborators: American Diabetes Association
Study start: 24 Jan 2023 (actual)
Primary completion: 20 May 2025 (actual)
Study completion: 20 May 2025 (actual)
First posted: 16 May 2023 (actual)
Results: Posted 29 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intermittent energy restriction (IER)	Experimental	Behavioral: Intermittent energy restriction (IER)Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week
Time-restricted eating (TRE)	Experimental	Behavioral: Time Restricted Eating (TRE)Intermittent fasting using an 8-hour eating period.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Intermittent energy restriction (IER)
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.	Behavioural	Time-restricted eating (TRE)

Primary outcome

Retention
Time frame: 52 weeks
Feasibility of IER and TRE over one year assessed by participant retention (% of participants completed).
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)

2 secondary outcomes

HbA1c
Time frame: Change from baseline to 24 weeks
Postprandial Glucose
Time frame: Change from baseline to 24 weeks

Results and safety

Results posted to the registry on 29 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intermittent Energy Restriction (IER)	29	21
Time-restricted Eating (TRE)	28	24

Primary outcome: Retention

Time frame: 52 weeks. Count of participants. Unit: Participants

Measure	Intermittent Energy Restriction (IER) n = 29	Time-restricted Eating (TRE) n = 28
Value	21	24

Primary outcome: Adherence to Diet Protocols

Time frame: Weekly from baseline to 52 weeks. Mean (Standard Deviation). Unit: Percent of weeks

Measure	Intermittent Energy Restriction (IER) n = 29	Time-restricted Eating (TRE) n = 28
Value	40.2 (21.9)	39.2 (29.2)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to the end of the intervention at 52 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intermittent Energy Restriction (IER)	0 of 29 (0%)	17 of 29 (58.6%)	0 of 29
Time-restricted Eating (TRE)	0 of 28 (0%)	12 of 28 (42.9%)	0 of 28

Limitations and caveats (from the sponsor): Limitations include the variability that heterogenous medication usage may have introduced. Next, participants were not blinded to randomization and self-reported adherence to the interventions. Finally, mechanistic indices of insulin sensitivity and β-cell function were highly variable and limited by measurement precision.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
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Active, not recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent energy restriction (IER) and Time Restricted Eating (TRE) in people with Type 2 Diabetes, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05860413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.