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A Pilot Study of Ketogenic Diet and Metformin in Glioblastoma: Feasibility and Metabolic Imaging | Clinical Trials | Clareo Health

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A Pilot Study of Ketogenic Diet and Metformin in Glioblastoma: Feasibility and Metabolic Imaging

NCT04691960•Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

This clinical trial is for men and women with high-grade gliomas. Glucose (sugar) is thought to be a contributor to tumor growth. The ketogenic diet (a high fat, low carbohydrate diet) and metformin (a drug approved by the Food and Drug Administration to treat type 2 diabetes) are both known to lower blood glucose levels. The purpose of the study is to evaluate the tolerability of a ketogenic diet in conjunction with metformin and whether maintaining and the diet with metformin will have any effect on participants. Participants will prepare their own meals with the help of a nutritionist. Participants will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+17 more criteria

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.

Locations (2)

Columbia University

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

Key Dates

Start Date

August 1, 2016

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

December 19, 2025

Enrollment

ACTUAL participants

Conditions

Glioblastoma

Interventions

Ketogenic Diet

OTHER

Metformin

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pilot Study of Ketogenic Diet and Metformin in Glioblastoma: Feasibility and Metabolic Imaging

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

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