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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

Study 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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PET: glucose uptake and neurotransmitter production with and without ketone supplement
Glucose
Glucose
Secondary outcome measures
Brain

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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,929 Previous Clinical Trials
13,198,234 Total Patients Enrolled
21 Trials studying Insulin Resistance
1,135 Patients Enrolled for Insulin Resistance
Martinos Center for Biomedical ImagingOTHER
7 Previous Clinical Trials
340 Total Patients Enrolled
1 Trials studying Insulin Resistance
80 Patients Enrolled for Insulin Resistance
Lilianne Mujica-Parodi, PhDPrincipal InvestigatorStony Brook University
2 Previous Clinical Trials
74 Total Patients Enrolled

Media Library

Glucose (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04840095 — Phase 4
Insulin Resistance Research Study Groups: Metabolic Manipulation via Ketone Supplement MR/PET, Metabolic Manipulation via Diet fMRI, Metabolic Manipulation via Ketone Supplement fMRI
Insulin Resistance Clinical Trial 2023: Glucose Highlights & Side Effects. Trial Name: NCT04840095 — Phase 4
Glucose (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04840095 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Maine
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Martinos Center for Biomedical Research, Building 149
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Dynamic Connectivity Under Metabolic Constraints
Lilianne R. Strey 2015. "Dynamic Connectivity Under Metabolic Constraints". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04840095.
~8 spots leftby Apr 2025
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