← Back to Search

Beta-hydroxybutyrate for Low Blood Sugar

Phase 1
Waitlist Available
Led By Raimund Herzog, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 1 diabetes mellitus of > 5 years (C-peptide negative, age 18-60 years, on intensive insulin therapy (HbA1c <7.5%)
Non-diabetic volunteers, age 18-65 years that do not meet any of the
Timeline
Screening 3 weeks
Treatment Varies
Follow Up under clamped hypoglycemia (50 min from start)
Awards & highlights

Study Summary

This trial will test if giving the body ketones will help type 1 diabetics during low blood sugar episodes and improve their thinking. If successful, it could lead to using ketones as a therapy to protect type 1 diabetics' brains during low blood sugar events.

Eligible Conditions
  • Low Blood Sugar
  • Type 1 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~under clamped hypoglycemia (50 min from start)
This trial's timeline: 3 weeks for screening, Varies for treatment, and under clamped hypoglycemia (50 min from start) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognitive Function

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Type 1 diabetic subjectsExperimental Treatment2 Interventions
Subjects will undergo a hyperinsulinemic-hypoglycemic clamp with a target glucose level of 55mg/dl. Once a stable glycemic state is reached, subjects will receive a bolus-continuous infusion beta-hydroxybutyrate (BHB) or infusion of a comparable volume of normal saline (placebo) to control for possible volume effects for the remainder of the study. Throughout the BHB or saline infusion cognitive function will be tested via a standardized testing battery.
Group II: Healthy Subjects CONTROLActive Control1 Intervention
Healthy control subjects will undergo a hyperinsulinemic-hypoglycemic clamp with a target glucose level of 55mg/dl. Once a stable glycemic state is reached, subjects will undergo an NMR test to characterize brain metabolism under hypoglycemia.
Group III: Healthy SubjectsActive Control2 Interventions
Healthy control subjects will undergo a hyperinsulinemic-hypoglycemic clamp with a target glucose level of 55mg/dl. Once a stable glycemic state is reached, subjects will receive a bolus-continuous infusion beta-hydroxybutyrate (BHB) or infusion of a comparable volume of normal saline (placebo) to control for possible volume effects for the remainder of the study. Throughout the BHB or saline infusion cognitive function will be tested via a standardized testing battery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Beta-hydroxybutyrate
2013
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,836 Previous Clinical Trials
2,727,229 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,337 Previous Clinical Trials
4,319,463 Total Patients Enrolled
Raimund Herzog, MDPrincipal InvestigatorYale School of Medicine
5 Previous Clinical Trials
134 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Mar 2025