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Diazoxide + Naloxone for Low Blood Sugar Prevention
Study Summary
This trial is testing whether two drug treatments can prevent unawareness of hypoglycemia in diabetics and improve the body's response to low blood sugar. Only healthy non-diabetics are being studied.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- People who are between 21 and 55 years old and do not have diabetes.You have significant problems with your body's salt and mineral levels.You have a serious liver problem.You smoke more than 10 cigarettes per day.You have a serious problem with your kidneys.You drink a lot of alcohol.You have ongoing health issues like liver disease, heart problems, bleeding disorders, cancer, HIV/AIDS, seizures, or rheumatologic conditions.You have mental health conditions that are not being managed well.You have a significant issue with your platelet levels.You have a significant level of anemia that could affect your health.You have a body mass index (BMI) higher than 35, which means you are significantly overweight.Your close family members have had diabetes or died from heart problems at a young age.Your urine test shows important problems.You have tested positive for certain drugs like amphetamines, cocaine, or opioids.You have had surgery on your hormone-producing glands.You have a significant increase or decrease in your white blood cell count that is causing health problems.You are currently taking beta-blockers or medications that affect how your body responds to low blood sugar.Your blood pressure is consistently very high (over 150/90) or very low (under 90/60) on multiple occasions.Your triglycerides are higher than 400 mg/dL or your total cholesterol is higher than 300 mg/dL.
- Group 1: Placebo (for Naloxone)
- Group 2: Placebo (for naloxone) + placebo (for diazoxide)
- Group 3: Naloxone + diazoxide
- Group 4: No intervention (Susceptibility to HAAF evaluation)
- Group 5: Naloxone
- Group 6: Diazoxide + placebo (for naloxone)
- Group 7: Naloxone + placebo (for diazoxide)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are engaged in this research effort?
"As of this moment, no longer actively accepting applicants for the clinical trial that was initially posted on 8/10/2018 and most recently updated 3/15/2023. If you are seeking alternative studies, there are 441 trials recruiting patients with hypoglycaemia, as well as 42 other medical studies studying the combination of Naloxone + diazoxide."
Are there any documented cases of using Naloxone and diazoxide in tandem?
"Currently, there are 42 trials that investigate the therapeutic effects of Naloxone + diazoxide. Of those studies, nine have entered Phase 3 clinical trials and can be accessed in 129 different locations around Bronx, New york."
Has the synthesis of Naloxone and diazoxide been validated by governmental regulations?
"There is established evidence that Naloxone + diazoxide combo therapy is safe, so it earned a mark of 3."
Is this experiment currently recruiting participants?
"Unfortunately, this trial is not seeking participants at the moment. It was originally published on August 10th 2018 and its last update occurred on March 15th 2023. On the other hand, if you are looking for alternative studies, 441 clinical trials related to low blood sugar are currently open while 42 research projects focusing on Naloxone + diazoxide also require volunteers."
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