Dichloroacetate for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how dichloroacetate affects brain function when blood sugar drops too low in people with Type 1 Diabetes. The trial aims to determine if dichloroacetate can help manage hypoglycemia (low blood sugar) episodes, which can be dangerous if not treated quickly. Participants will receive either dichloroacetate or a placebo (a harmless pill with no effect) to compare results. Individuals with Type 1 Diabetes who have a history of severe low blood sugar episodes, especially those requiring assistance during these episodes, might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how dichloroacetate works in people, offering participants a chance to contribute to groundbreaking diabetes treatment research.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that dichloroacetate is likely to be safe for humans?
Research shows that dichloroacetate (DCA) has been safely used in humans for over 40 years. People with a rare metabolic disorder have received it without serious side effects. In some studies, participants reported mild sleepiness, but nothing severe.
Other studies tested DCA in people with diabetes for a week and found no major safety concerns. The long history of DCA use and various studies suggest it is generally well-tolerated. However, since this trial is in an early stage, limited information exists on its safety specifically for this condition.12345Why do researchers think this study treatment might be promising for Type 1 Diabetes?
Most treatments for Type 1 Diabetes, like insulin therapy, focus on managing blood sugar levels. But Dichloroacetate works differently by targeting the underlying metabolism. Researchers are excited because it has the potential to improve how the body uses glucose, which could reduce the reliance on frequent insulin injections. This unique mechanism could offer a new way to manage Type 1 Diabetes, making life easier for patients.
What evidence suggests that dichloroacetate might be an effective treatment for type 1 diabetes?
Research has shown that dichloroacetate (DCA) may benefit people with diabetes. In clinical trials, DCA lowered blood sugar levels in diabetic patients after just 6 to 7 days of oral administration. It has been safely used in humans for a long time, particularly for a rare metabolic disorder. Animal studies also suggest that DCA can improve diabetes-related issues, such as cataracts and nerve problems. This trial will evaluate DCA's potential to help manage Type 1 Diabetes symptoms, especially during low blood sugar episodes. Participants in this trial will receive either DCA or a placebo.12346
Who Is on the Research Team?
Raimund Herzog, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for people with Type 1 Diabetes who've had severe low blood sugar episodes or don't feel when their blood sugar gets too low. They should have needed help due to low blood sugar or had multiple very low readings on a continuous glucose monitor before the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dichloroacetate or placebo in a crossover design to assess brain glucose metabolism under clamped hypoglycemia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dichloroacetate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor