Type2DiabetesSFS3NCT05290246
TRE in Type 2 Diabetes (See Food Study 3)
A study testing Time restricted eating and Caloric reduction in people with Type2Diabetes, run by University of Minnesota at 1 site in United States.
Trial summary
Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2Diabetes
- What is being tested?
- Time restricted eating and Caloric reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2022to 23 Mar 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/obese adults with metformin-only treated type 2 diabetes
- 18-65 years old
- BMI:25-45 kg/m2
- HbA1c: 6.5-8.5%
- Self-reported weight must be stable [±5 pounds] for at least 3 months prior to the study
- Owns a smartphone.
Who cannot join
- Active or anticipated pregnancy during the study
- type 2 diabetes treated with medications other than metformin
- presence of eating disorders as noted by screening survey.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: TRE in Type 2 Diabetes Mellitus (See Food Study 3)
Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. This study proposes a 24 week feasibility study to test if TRE is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients [BMI:25-45 kg/m2] with metformin-only treated Type 2 diabetes.
- Conditions
- Type2Diabetes
- Being tested
- Time restricted eating, Caloric reduction
- Keywords
- Type 2 diabetes, diet intervention, intermittent fasting, caloric restriction, time restricted eating
- Medical subject headings
- Diabetes Mellitus, Type 2, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Limiting daily eating time to an 8 hour window
Caloric reductionBehavioural
Cut caloric intake by 15%
| Study group | Role | What they receive |
|---|---|---|
| Time restricted eating | Experimental | daily 8 hour eating window Receives: Behavioral: Time restricted eating |
| Caloric Restriction | Active comparator | reduction of caloric intake by 15% Receives: Behavioral: Caloric reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycemic Measures- HbA1c (12w)
Change in hemoglobin A1c
Measured: 12 weeks
Secondary outcomes (11)
Weight Change (12w)
Change in weight from baseline
Measured: 12 weeks
Weight Change (24w)
Change in weight from baseline
Measured: 24 weeks
Change in Glycemic Measures- Insulin (12w)
Change in fasting insulin
Measured: 12 weeks
Change in Glycemic Measures- Insulin (24w)
Change in fasting insulin
Measured: 24 weeks
Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (24w)
Change in Homeostatic Model Assessment for Insulin Resistance
Measured: 24 weeks
Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (12w)
Change in fasting Homeostatic Model Assessment for Insulin Resistance
Measured: 12 weeks
Change in Glycemic Measures- HbA1c (24w)
Change in hemoglobin A1c
Measured: 24 weeks
Change in Glycemic Measures- Glucose (24w)
Change in continuous glucose monitoring
Measured: 24 weeks
Change in Glycemic Measures- Glucose (12w)
Change in continuous glucose monitoring
Measured: 12 weeks
Intervention Burden (12w)
Participant self-report via survey
Measured: 12 weeks
Intervention Burden (24w)
Participant self-report via survey
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start27 May 2022
- Primary completion12 Dec 2025
- Study completion23 Mar 2026
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 Type2DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Chow, MD, Principal investigator, University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290246
- Sponsor's protocol ID
- MED-2022-30316
- Acronym
- SFS3
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2022
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRE in Type 2 Diabetes Mellitus (See Food Study 3)
- ClinicalTrials.gov ID
- NCT05290246
- Acronym / sponsor ID
- SFS3 / MED-2022-30316
- Conditions
- Type2Diabetes
- Keywords
- Type 2 diabetes, diet intervention, intermittent fasting, caloric restriction, time restricted eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. This study proposes a 24 week feasibility study to test if TRE is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients [BMI:25-45 kg/m2] with metformin-only treated Type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating | Experimental | Behavioral: Time restricted eatingdaily 8 hour eating window |
| Caloric Restriction | Active comparator | Behavioral: Caloric reductionreduction of caloric intake by 15% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Overweight/obese adults with metformin-only treated type 2 diabetes
- 18-65 years old
- BMI:25-45 kg/m2
- HbA1c: 6.5-8.5%
- Self-reported weight must be stable [±5 pounds] for at least 3 months prior to the study
Key exclusion criteria (3 listed)
- Active or anticipated pregnancy during the study
- type 2 diabetes treated with medications other than metformin
- presence of eating disorders as noted by screening survey.
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 |
|---|---|---|
| Time restricted eatingLimiting daily eating time to an 8 hour window | Behavioural | Time restricted eating |
| Caloric reductionCut caloric intake by 15% | Behavioural | Caloric Restriction |
Primary outcome
Change in Glycemic Measures- HbA1c (12w)
Time frame: 12 weeks
Change in hemoglobin A1c
11 secondary outcomes
Weight Change (12w)
Time frame: 12 weeks
Weight Change (24w)
Time frame: 24 weeks
Change in Glycemic Measures- Insulin (12w)
Time frame: 12 weeks
Change in Glycemic Measures- Insulin (24w)
Time frame: 24 weeks
Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (24w)
Time frame: 24 weeks
Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (12w)
Time frame: 12 weeks
Change in Glycemic Measures- HbA1c (24w)
Time frame: 24 weeks
Change in Glycemic Measures- Glucose (24w)
Time frame: 24 weeks
Change in Glycemic Measures- Glucose (12w)
Time frame: 12 weeks
Intervention Burden (12w)
Time frame: 12 weeks
Intervention Burden (24w)
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lisa Chow, MD principal investigator
University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating and Caloric reduction in people with Type2Diabetes, run by University of Minnesota 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 3 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 14 Apr 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 18 Mar 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?
Change in Glycemic Measures- HbA1c (12w) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.