Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01462227
First received: October 26, 2011
Last updated: February 17, 2016
Last verified: February 2016
Results First Received: January 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypoglycemia
Interventions: Drug: Naltrexone High Dose
Drug: Naltrexone Low Dose

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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
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
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
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

Participant Flow for 2 periods

Period 1:   First Assignment
    Naltrexone (Lower Dose) First /Placebo Second     Placebo First/ Naltrexone (Lower Dose) Second     Naltrexone (Higher Dose) First /Placebo Second     Placebo First / Naltrexone (Higher Dose) Second  
STARTED     4     2     6     5  
COMPLETED     4     2     6     5  
NOT COMPLETED     0     0     0     0  

Period 2:   Second Assignment
    Naltrexone (Lower Dose) First /Placebo Second     Placebo First/ Naltrexone (Lower Dose) Second     Naltrexone (Higher Dose) First /Placebo Second     Placebo First / Naltrexone (Higher Dose) Second  
STARTED     4     2     6     5  
COMPLETED     3     1     5     5  
NOT COMPLETED     1     1     1     0  
Lost to Follow-up                 1                 0                 0                 0  
Protocol Violation                 0                 1                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline population includes subjects that completed study

Reporting Groups
  Description
Naltrexone (Lower Dose) Naltrexone: Naltrexone 50 mg, 1 tablet given every 12 hours orally
Naltrexone (Higher Dose) Naltrexone: Naltrexone 100mg, 1 tablet given every 12 hours orally
Total Total of all reporting groups

Baseline Measures
    Naltrexone (Lower Dose)     Naltrexone (Higher Dose)     Total  
Number of Participants  
[units: participants]
  4     10     14  
Age  
[units: years]
Mean (Standard Deviation)
  32.3  (11)     32.4  (12)     32.4  (11)  
Gender  
[units: participants]
     
Female     2     4     6  
Male     2     6     8  



  Outcome Measures
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1.  Primary:   Glucose (mg/dL)   [ Time Frame: End of study (up to 240 minutes) ]

2.  Primary:   Glucose Infusion Rate (mg/kg.Min)   [ Time Frame: End of study (up to 240 minutes) ]

3.  Secondary:   Glucagon (pg/mL)   [ Time Frame: End of study (up to 240 minutes) ]

4.  Secondary:   Cortisol (ug/dL)   [ Time Frame: End of study (up to 240 minutes) ]

5.  Secondary:   Epinephrine (pg/mL)   [ Time Frame: End of study (up to 240 minutes) ]

6.  Secondary:   Norepinephrine (pg/mL)   [ Time Frame: End of study (up to 240 minutes) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert Stanley Sherwin, MD
Organization: Yale University
phone: 203 737 1932
e-mail: robert.sherwin@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01462227     History of Changes
Other Study ID Numbers: HIC1006006927
Study First Received: October 26, 2011
Results First Received: January 20, 2016
Last Updated: February 17, 2016
Health Authority: United States: Institutional Review Board