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

• Status: Suspended
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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 two medications, 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine, Inc.
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Treatments: Diazoxide; Naloxone

Criteria

Inclusion Criteria:

-Healthy, non-diabetic subjects 21-55 years old

Exclusion Criteria:

• BMI >35kg/m2

• BP >150/90 or <90/60 on repeated measurements and on more than one occasion

• Triglycerides >400 mg/dL and/or total cholesterol >300 mg/dL

• Clinically significant liver dysfunction

• Clinically significant kidney dysfunction

• Clinically significant anemia

• Clinically significant leukocytosis or leukopenia

• Clinically significant thrombocytopenia or thrombocytosis

• Positive drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, oxycodone, PCP

• Currently taking beta-blockers or medications that affect counterregulatory response to hypoglycemia

• Urinalysis: clinically significant abnormalities

• Clinically significant electrolyte abnormalities

• Smoking >10 cigarettes/day

• Heavy alcohol use

• History of chronic conditions (eg, chronic liver disease, cardiovascular disease, bleeding disorders, cancer, HIV/AIDS, seizures, systemic rheumatologic conditions)

• Surgeries involving endocrine glands

• Pregnancy

• Enrollment in another medication intervention study less than one month prior, besides those done by our group

• Family history of diabetes or premature cardiac death in first degree relatives

• Allergies to medications given during study

• Uncontrolled psychiatric disorders