Clinical Trial

Prevention of Hypoglycemia Associated Autonomic Failure

Study Description

Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)

The overall goal of this study is to develop a new and practical way to prevent the development of Hypoglycemia Associated Autonomic Failure (HAAF), which is unawareness of hypoglycemia (low blood sugar) in individuals with diabetes. Previous studies suggest that both naloxone and diazoxide may increase the body's ability to respond to episodes of low blood sugar and prevent the development of HAAF (or hypoglycemia unawareness). Only healthy subjects are being recruited for this study. The study has three distinct phases. In the first phase, healthy, non-diabetic individuals who are susceptible to developing HAAF are identified. Only these individuals will be studied in the second and third phases. The second phase of this study evaluates the effect of using a naloxone nasal spray versus a placebo nasal spray in improving the body's response to episodes of low blood sugar and in preventing the development of HAAF. The third phase of this study evaluates the effect of using naloxone nasal spray and diazoxide in combination, compared to naloxone nasal spray plus a placebo (for diazoxide) or diazoxide plus a placebo (for naloxone) in improving the body's response to episodes of low blood sugar and in preventing the development of HAAF.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Naloxone

Naloxone Nasal Spray

Drug - Diazoxide

Diazoxide (oral)

Drug - Placebo (for Naloxone)

Sterile water nasal spray

Drug - Placebo (for Diazoxide)

Taste matched oral placebo for diazoxide

Additional Information

Official Study Title

Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)

Clinical Trial ID

NCT03608163

ParticipAid ID

bW6nQa