| Trial ID: | L3429 |
| Source ID: | NCT03608163
|
| Associated Drug: |
Naloxone
|
| Title: |
Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1|Hypoglycemia|Hypoglycemia Unawareness
|
| Interventions: |
DRUG: Naloxone|DRUG: Diazoxide|DRUG: Placebo (for Naloxone)|DRUG: Placebo (for Diazoxide)
|
| Outcome Measures: |
Primary: Difference in peak epinephrine levels between first and third hypoglycemic episodes, Small blood samples will be taken every 15 minutes throughout clamp procedures and analyzed using high performance liquid chromatography to measure epinephrine levels. The difference in peak epinephrine levels between the first and third episodes of hypoglycemia under various treatment conditions (eg, no medication, naloxone, diazoxide, naloxone/diazoxide and matched placebos) will be reported., Every 15 minutes during first and third hypoglycemic clamp procedures (on Day 1 and Day 2 of two day study) | Secondary: Endogenous glucose production (EGP), Rates of EGP (a measure of the body's production of sugar) will be measured during the third hypoglycemic clamp procedure on the second day of clamp studies under various treatment conditions (eg, no medication, naloxone, diazoxide, naloxone/diazoxide and matched placebos), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar)., Every 15 minutes during the third 2-hour hypoglycemic clamp procedure (on Day 2 of the two day study)|Symptoms of low blood sugar (hypoglycemia), Determined using the Edinburgh Hypoglycemia Symptom Scale Score which determines the participant's awareness of eleven specific symptoms of hypoglycemia. Each symptom is scored 0-1 (0=not present or 1=present), which are then added together to yield a total between 0-11. Higher values mean participant has greater awareness of hypoglycemia, lower values mean participant has impaired awareness of hypoglycemia., Every 15 minutes during the first and third 2-hour hypoglycemic episodes (on Day 1 and Day 2)
|
| Sponsor/Collaborators: |
Sponsor: Albert Einstein College of Medicine | Collaborators: National Institutes of Health (NIH)|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
17
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2018-08-10
|
| Completion Date: |
2023-12-15
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-17
|
| Locations: |
Albert Einstein College of Medicine, Bronx, New York, 10461, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03608163
|
