Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02471040 · ClinicalTrials.gov registry record · Phase 1
Brain Ketone Metabolism in Type 1 Diabetes
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT02471040: Completed Phase 1 study, sponsored by Yale University.
NCT02471040 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02471040, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
This study is designed to examine the value of infusing BHB in type 1 diabetic subjects during experimentally induced hypoglycemic episode in conjunction with testing of cognitive function. This will lay the basis for subsequent trials exploring the novel use of therapeutic doses of oral ketone formulations that are currently under commercial development, which could serve as adjunct therapies to protect the brain from hypoglycemia in type 1 diabetic subjects experiencing recurrent hypoglycemia.
Primary Outcome
Subjects from all groups will be studied using the NIH Toolbox Cognition Battery, which includes measurements of Executive Function, Attention, Episodic Memory, Language, Processing Speed and Working Memory.
Interventions
- OTHER Normal Saline
- DRUG Beta-hydroxybutyrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2013-05-14 |
| Est. Completion | 2022-04-04 |
| Phase | Phase 1 |
What the finished NCT02471040 record still lists
NCT02471040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT02471040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02471040 about?
NCT02471040 is a clinical study titled "Brain Ketone Metabolism in Type 1 Diabetes". This study is designed to examine the value of infusing BHB in type 1 diabetic subjects during experimentally induced hypoglycemic episode in conjunction with testing of cognitive function. This will lay the basis for subsequent trials exploring the novel use of therapeutic doses of oral ketone form...
What is the current status of trial NCT02471040?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2013-05-14. Estimated completion is 2022-04-04.
What interventions are being tested in trial NCT02471040?
The interventions under investigation include: Normal Saline (OTHER), Beta-hydroxybutyrate (DRUG).
Who is sponsoring clinical trial NCT02471040?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02471040's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02323945 · 44 participants · NA
Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury
- NCT03093909 · 44 participants · Phase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
- NCT03104491 · 44 participants · Phase 1
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
- NCT03781765 · 44 participants · Phase 4
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI