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Can a keto diet and metformin starve brain tumors?

NCT ID NCT04691960

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a ketogenic diet (high fat, low carb) combined with the diabetes drug metformin is safe and tolerable for people with glioblastoma, an aggressive brain cancer. The idea is to lower blood sugar, which tumors use to grow. The 18 participants prepare their own meals with a nutritionist's help. The main goals are to see if they can stick with the diet and tolerate metformin, not yet to measure tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketogenic diet and metformin
What this could lead to
If this approach works, it could point toward a new way to slow glioblastoma growth by cutting off the sugar that tumors need to thrive.
What could go wrong
This is a very small, early pilot study with only 18 participants. It focuses on feasibility and tolerability, not on whether the diet and drug actually shrink tumors or extend survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

Aug 2016

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients must have histologically confirmed high-grade glioma (e.g. glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma or other anaplastic gliomas). 2. Patients must have an MRI performed within 21 days prior to beginning the study diet and on a fixed dose of steroids for at least 5 days. If the steroid dose is increased between the date of imaging and registration, a new baseline MR/CT is required. 3. Patients must not have been exposed to bevacizumab. 4. Patients cannot be taking insulin or other oral hypoglycemic. Must be at least 6 weeks from last oral hypoglycemic or insulin. 5. Must not have known type 1 or type 2 diabetes and expected to need either insulin and/or an oral hypoglycemic agents within the next 6 months. 6. Patients must be \>18 years old. 7. Karnofsky performance status \>60%. 8. Life expectancy of greater than 12 weeks. 9. Patients must have normal organ and marrow function as defined below: * Leukocytes \>3,000/mcL * Absolute neutrophil count \>1,000/mcL * Platelets \>100,000/mcL * Total bilirubin \<2.0 X institutional upper limit of normal (unless known to have Gilbert's Disease) * AST (SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal * Serum Glucose: \< 200 mg/dL * Creatinine \< 1.5 mg/dL (for males), \< 1.4 mg/dL (for females), or within normal lab limits OR * Creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 10. Patients must not have any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patients' ability to tolerate this therapy 11. Patients having undergone recent resection or progressive tumor will be eligible as long as all of the following conditions apply: 1. They have recovered from the effects of surgery. 2. On a steroid dosage that has been stable for at least 5 days. 3. Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease postoperatively, a MRI should be done: * No later than 96 hours in the immediate post-operative period or * At least 4 weeks post-operatively, and * Within 14 days of registration, and * If the 96-hour scan is more than 21 days before registration, the scan needs to be repeated. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI is required on a stable steroid dosage for at least 5 days. 12. Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients who are receiving any other investigational agents. 2. Patients who have had prior therapy with bevacizumab and/or other VEGF inhibitors. 3. Patients who are taking insulin or other oral hypoglycemic. Must be at least 6 weeks from last oral hypoglycemic or insulin. 4. History of allergic reactions attributed to metformin. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, diabetes requiring oral hypoglycemic drugs and/or insulin, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Patients known to have a malignancy that has required treatment in the last 12 months and/or is expected to require treatment in the next 12 months (except nonmelanoma skin cancer or carcinoma in-situ in the cervix). 7. The effects of a Ketogenic diet or metformin on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 8. Patients with current alcoholism.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Columbia University

    New York, New York, 10032, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

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