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

PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Glioblastoma
Interventions
OTHER

Ketogenic Diet

Ketogenic diet is high-fat, low carbohydrate diet. Ketogenic diet will be maintained on a continuous basis. The diet will begin at an approximately 3:1 fat to carbohydrate + protein ratio for 5 days. If the patient does not show urine ketosis (1.5 mmol/L or 27.0 mg/dL), the ketosis diet will be advanced to approximately 4:1 ratio for 5 days. If the patient still does not attain ketosis a 24 hour fast will be done to promote ketosis. The diet will encourage at least 30 ml per day of Medium Chain Triglycerides (MCT) oil to enhance ketosis.

DRUG

Metformin

Metformin will be administered as a single 850 mg dose P.O. at Week 8, then titrated up to 850 mg P.O. BID at Week 10, and then 850 mg T.I.D. at Week 12, as tolerated.

Trial Locations (2)

10032

RECRUITING

Columbia University, New York

10065

RECRUITING

Weill Cornell Medicine, New York

All Listed Sponsors
lead

Weill Medical College of Cornell University

OTHER

NCT04691960 - A Pilot Study of Ketogenic Diet and Metformin in Glioblastoma: Feasibility and Metabolic Imaging | Biotech Hunter | Biotech Hunter