Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
This study is currently recruiting participants.
Verified October 2011 by Yale University
Sponsor:
Yale University
Collaborator:
Information provided by (Responsible Party):
Robert Sherwin, Yale University
ClinicalTrials.gov Identifier:
NCT01462227
First received: October 26, 2011
Last updated: October 28, 2011
Last verified: October 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 26, 2011 | ||||||||
| Last Updated Date | October 28, 2011 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Hormone Levels [ Time Frame: 240 minutes ] [ Designated as safety issue: No ] Glucagon and catecholamine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with naltrexone. These levels will be checked every 30 minutes during the 240 minute study session. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01462227 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia | ||||||||
| Official Title ICMJE | The Effect of Opiate Blockade With Naltrexone on Counterregulatory Mechanisms in Hypoglycemia | ||||||||
| Brief Summary | 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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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Hypoglycemia | ||||||||
| Intervention ICMJE | Drug: Naltrexone
Naltrexone 100mg for two administrations. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 15 | ||||||||
| Estimated Completion Date | August 2013 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01462227 | ||||||||
| Other Study ID Numbers ICMJE | HIC1006006927 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Robert Sherwin, Yale University | ||||||||
| Study Sponsor ICMJE | Yale University | ||||||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Yale University | ||||||||
| Verification Date | October 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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