Can a keto diet and metformin starve brain tumors?
NCT ID NCT04691960
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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18 people
The number who actually took part.
- Started
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Aug 2016
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Columbia University
New York, New York, 10032, United States
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Weill Cornell Medicine
New York, New York, 10065, United States
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