Summary
Time-restricted eating (Intermittent fasting) has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Type 2 Diabetes. ClinicalTrials.gov lists 8 registered trials linking Time-restricted eating (Intermittent fasting) to Type 2 Diabetes: 2 are currently recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT06845345). The largest enrolment is 144 participants (NCT07674875). Registration activity spans 2019 to 2026. No published literature item is linked to Time-restricted eating (Intermittent fasting) and Type 2 Diabetes in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Type 2 Diabetes Mellitus ranks 767 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: 1.6-1.7% at 7 years on standard care (population-level cohorts UK and US).
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 26.5 (trials 21.5, literature 0.0, tier 5, approved bonus 0.0) |
| Registered trials | 8 total: 2 recruiting, 0 active / not yet recruiting, 5 completed, 1 other |
| Linked publications | 0 |
| Agent type | Behavioural (Lifestyle) |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Potential dietary and lifestyle interventions for decreasing insulin resistance · Halma MTJ, Syed M, Marik PE · 2023 |
| Data sources | OSMF Chronic Disease Review |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT06845345 | Effect of an Early Time Restricted Eating Mediterranean Diet Compared to Naltrexone/Bupropion on Liver Fibrosis in People With Cardiometabolic Risk Factors in a Hospital Outpatient Clinic (MEDFAST-study) 2025 | enrolling by invitation | Phase 4 | 70 |
| NCT05290246 | TRE in Type 2 Diabetes (See Food Study 3) 2022 | completed | Not applicable | 115 |
| NCT04090840 | Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF) 2019 | completed | Not applicable | 51 |
| NCT05860413 | Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus 2023 | completed | Not applicable | 57 |
| NCT04283942 | Effect of Intermittent Calorie Restriction on MASLD Patients With Abnormal Glucose Metabolism 2020 | completed | Not applicable | 60 |
| NCT07674875 | Meal Frequency and Timing on Metabolic Health in Patients With Type 2 Diabetes 2024 | completed | Not applicable | 144 |
| NCT07272460 | Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial 2026 | recruiting | Not applicable | 112 |
| NCT03940482 | Time Restricted Eating As Treatment (TREAT) for Diabetes Mellitus: A Pre-Post 12 Week Study on the Effectiveness of Intermittent Fasting in Asians With Type 2 Diabetes Mellitus 2019 | status unknown | Not applicable | 50 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: Potential dietary and lifestyle interventions for decreasing insulin resistance · Halma MTJ, Syed M, Marik PE · 2023.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Time-restricted eating (Intermittent fasting) approved for Type 2 Diabetes?
Time-restricted eating (Intermittent fasting) has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Type 2 Diabetes. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Time-restricted eating (Intermittent fasting) in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Time-restricted eating (Intermittent fasting) to Type 2 Diabetes: 2 are currently recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT06845345). The largest enrolment is 144 participants (NCT07674875). Registration activity spans 2019 to 2026.
What does the evidence show for Time-restricted eating (Intermittent fasting) in Type 2 Diabetes?
Time-restricted eating (Intermittent fasting) has 5 completed registered trials for Type 2 Diabetes but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.