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Ketones for Insulin Resistance

Phase 4

Recruiting

Led By Lilianne Mujica-Parodi, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within two weeks of enrollment completion

Awards & highlights

Drug Has Already Been Approved

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trialinvestigates how insulin resistance affects brain aging & whether alternate metabolic pathways (ketones vs. glucose) can counteract it. Subjects will be tested in a within-subjects design with neuroimaging & cognitive tasks, monitored with blood tests.

Eligible Conditions

Insulin Resistance
Healthy Subjects
Diet Modification
Aging

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within two weeks of enrollment completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within two weeks of enrollment completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and within two weeks of enrollment completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PET: glucose uptake and neurotransmitter production with and without ketone supplement

Glucose

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Metabolic Manipulation via Ketone Supplement fMRIExperimental Treatment2 Interventions

All subjects are tested twice, both times in a fasting condition (8 hours no food, unrestricted water). While having their brains scanned with MRI, subjects are initially tested at rest, and then perform a task. Midway through the session, subjects are removed from the scanner and drink either of two fuel sources. In the ketotic (ketone burning) session they will drink a ketone sports drink dosed at 395mg/kg. During the glycolytic (glucose burning) session the same subjects will drink a bolus of glucose, calorie-matched to the ketones. Our data analyses quantify network reorganization in response to changing energy constraints (i.e., cognitive demand, fuel).

Group II: Metabolic Manipulation via Ketone Supplement MR/PETExperimental Treatment2 Interventions

All subjects are tested twice, both times in a fasting condition (8 hours no food, unrestricted water). For both sessions, we will intravenously administer the FDG radioisotope continuously throughout the scan. Thus, PET will map glucose uptake across the brain, while we simultaneously use MRS to measure production of the neurotransmitters glutamine and GABA. While having their brains scanned with MR/PET, subjects are initially tested at rest, and then perform a task. Subjects will drink a ketone sports drink dosed at 395mg/kg. During the glycolytic (glucose burning) session the same subjects will drink a bolus of glucose, calorie-matched to the ketones.

Group III: Metabolic Manipulation via Diet fMRIExperimental Treatment1 Intervention

All subjects are tested three times, each in a different diet-induced metabolic state: glycolytic (glucose burning), fasting (8 hours no food), and ketotic (fat burning). While having their brains scanned with MRI, subjects are initially tested at rest, and then perform a task. Midway through the session, subjects are removed from the scanner and drink up to 75g glucose. Our data analyses quantify network reorganization in response to changing energy constraints (i.e., cognitive demand, fuel).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dextrose, unspecified form

FDA approved

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