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Ketogenic Diet + Metformin for Glioblastoma
Phase 2
Recruiting
Led By Howard Fine, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Patients must not have been exposed to bevacizumab.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (an average of 8 months)
Awards & highlights
Study Summary
This trial is for people with high-grade gliomas. The ketogenic diet and metformin are both known to lower blood sugar levels. The purpose of the study is to see if the ketogenic diet, with metformin, is tolerable and has any effect on participants.
Who is the study for?
This trial is for adults over 18 with high-grade gliomas who haven't had bevacizumab therapy. They should not have diabetes requiring medication, no recent malignancy treatments (except certain skin cancers), and no severe illnesses that could affect study participation. Participants must be able to prepare meals and follow a ketogenic diet with metformin, without experiencing unacceptable side effects.Check my eligibility
What is being tested?
The trial tests the combination of a ketogenic diet and metformin on patients with high-grade gliomas. The goal is to see if this regimen can lower blood glucose levels which may contribute to slowing tumor growth. Patients will work with a nutritionist to manage their diet while taking metformin.See study design
What are the potential side effects?
Potential side effects include low blood sugar, digestive issues from the ketogenic diet such as constipation or diarrhea, changes in cholesterol levels, weight loss, and possible vitamin deficiencies. Metformin may cause stomach upset or a rare condition called lactic acidosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had an MRI within the last 3 weeks and have been on a stable steroid dose for at least 5 days.
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I have never been treated with bevacizumab.
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I am older than 18 years.
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I am able to care for myself but may not be able to do active work.
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I do not have diabetes and don't expect to need diabetes medication soon.
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I have been diagnosed with a high-grade brain tumor.
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My kidney function is good.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (an average of 8 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (an average of 8 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability to achieve and maintain ketosis
Tolerability of metformin
Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ketogenic DietExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,259 Total Patients Enrolled
8 Trials studying Glioblastoma
464 Patients Enrolled for Glioblastoma
Howard Fine, MDPrincipal InvestigatorWeill Medical College of Cornell University
6 Previous Clinical Trials
562 Total Patients Enrolled
3 Trials studying Glioblastoma
118 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't need to be tumor-free after surgery to join the study.I do not have any serious illnesses that are not under control.I haven't taken insulin or diabetes pills for at least 6 weeks.I have not been treated for cancer (except skin cancer or cervical pre-cancer) in the last year and don't expect to need treatment in the next year.I had an MRI within the last 3 weeks and have been on a stable steroid dose for at least 5 days.I have never been treated with bevacizumab.I am older than 18 years.I am able to care for myself but may not be able to do active work.I am within 96 hours after my surgery.I do not have diabetes and don't expect to need diabetes medication soon.You have had allergic reactions to metformin in the past.My organ and bone marrow functions are normal.I have been diagnosed with a high-grade brain tumor.I haven't taken insulin or diabetes pills for at least 6 weeks.I don't have any serious illnesses that can't be managed and won't affect my treatment.My steroid dosage has been the same for at least 5 days.I recently had surgery for my tumor or it's growing, but meet all required conditions.My kidney function is good.I have previously been treated with bevacizumab or other drugs that target blood vessel growth.You are not currently taking any experimental medications.You are currently struggling with alcoholism.I had surgery at least 4 weeks ago.I agree to use birth control or abstain from sex during the study.I have fully recovered from any surgery effects.
Research Study Groups:
This trial has the following groups:- Group 1: Ketogenic Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have other research initiatives explored the potential benefits of a Ketogenic Diet?
"The present moment, 170 separate clinical trials are being conducted to evaluate the efficacy of a ketogenic diet. Of these studies, 43 have entered Phase 3 and 1903 locations across the USA are hosting research sites. Most notably, Pittsburgh is home to the largest concentration of Ketogenic Diet investigations."
Answered by AI
For what medical issues is a Ketogenic Diet typically prescribed?
"Ketogenic Diet is commonly prescribed to those who are physically active, but it can also be beneficial for the treatment of certain health issues such as type 1 diabetes mellitus and diabetic ketoacidosis or polycystic ovary syndrome."
Answered by AI
How many participants are involved in this investigation?
"Yes, according to clinicaltrials.gov records, this medical trial posted on August 1st 2016 is still recruiting participants. The study has adjusted its requirements since then and currently searches for 36 individuals that can be found across two different sites."
Answered by AI
Is the Ketogenic Diet sanctioned by the FDA?
"Taking into account the fact that this is a Phase 2 trial, which implies limited data regarding efficacy but some knowledge of safety, our team at Power has assigned Ketogenic Diet a rating of two."
Answered by AI
Does this research currently require more participants?
"Examining the clinicaltrials.gov information, it is clear that this trial has opened its doors to participants. It was initially advertised on August 1st 2016 and the latest update occured December 21th 2021."
Answered by AI
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