drugset / Trial / NCT04691960

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

NCT04691960 ↗

Phase 2 Active not recruiting 18 enrolled Weill Medical College of Cornell University
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2016-08
Primary completion
2026-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 850 mg Oral

Indications