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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it can also affect the levels of the hormones which are released during hypoglycemia. The aim of this study is to determine whether naltrexone can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone (higher dose) | Experimental | Naltrexone 100mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the high dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm. |
|
| Naltrexone (lower dose) | Experimental | Naltrexone 50mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the low dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone High Dose | Drug | Naltrexone 100mg for two administrations. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose (mg/dL) | Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study. | End of study (up to 240 minutes) |
| Glucose Infusion Rate (mg/kg.Min) | The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL). | End of study (up to 240 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon (pg/mL) | Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study. | End of study (up to 240 minutes) |
| Cortisol (ug/dL) | Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Sherwin, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone (Lower Dose) First /Placebo Second | Naltrexone 50 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally |
| FG001 | Placebo First/ Naltrexone (Lower Dose) Second | Placebo given given 12 hours prior to visit orally Naltrexone 50 mg (1 tablet) given at time of visit orally |
| FG002 | Naltrexone (Higher Dose) First /Placebo Second | Naltrexone 100 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally |
| FG003 | Placebo First / Naltrexone (Higher Dose) Second | Placebo given 12 hours prior to visit orally Naltrexone 100 mg (1 tablet) given at time of visit orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Assignment |
| |||||||||||||
| Second Assignment |
|
Baseline population includes subjects that completed study
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone (Lower Dose) | Naltrexone: Naltrexone 50 mg, 1 tablet given every 12 hours orally |
| BG001 | Naltrexone (Higher Dose) | Naltrexone: Naltrexone 100mg, 1 tablet given every 12 hours orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glucose (mg/dL) | Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study. | Subjects' data were pooled and only those that completed both visits are analyzed here. | Posted | Mean | Standard Deviation | mg/dL | End of study (up to 240 minutes) |
|
End of study, up to 240 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naltrexone (50 mg) | Naltrexone 50 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Stanley Sherwin, MD | Yale University | 203 737 1932 | robert.sherwin@yale.edu |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Naltrexone Low Dose |
| Drug |
Naltrexone 50mg for two administrations. |
|
| End of study (up to 240 minutes) |
| Epinephrine (pg/mL) | Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study. | End of study (up to 240 minutes) |
| Norepinephrine (pg/mL) | Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study. | End of study (up to 240 minutes) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Glucose Infusion Rate (mg/kg.Min) | The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL). | Subjects' data were pooled and only those that completed both visits are analyzed here. | Posted | Mean | Standard Deviation | mg/kg.min | End of study (up to 240 minutes) |
|
|
|
| Secondary | Glucagon (pg/mL) | Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study. | Subjects' data were pooled and only those that completed both visits are analyzed here. | Posted | Mean | Standard Deviation | pg/mL | End of study (up to 240 minutes) |
|
|
|
| Secondary | Cortisol (ug/dL) | Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study. | Subjects' data were pooled and only those that completed both visits are analyzed here. | Posted | Mean | Standard Deviation | ug/dL | End of study (up to 240 minutes) |
|
|
|
| Secondary | Epinephrine (pg/mL) | Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study. | Subjects' data were pooled and only those that completed both visits are analyzed here. | Posted | Mean | Standard Deviation | pg/mL | End of study (up to 240 minutes) |
|
|
|
| Secondary | Norepinephrine (pg/mL) | Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study. | Subjects' data were pooled and only those that completed both visits are analyzed here. | Posted | Mean | Standard Deviation | pg/mL | End of study (up to 240 minutes) |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Placebo (Lower Dose Group) | Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally). | 0 | 4 | 0 | 4 |
| EG002 | Naltrexone (100 mg) | Naltrexone 100 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally). | 0 | 10 | 5 | 10 |
| EG003 | Placebo (Higher Dose) | Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally). | 0 | 10 | 3 | 10 |
| Insomnia | General disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |