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Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

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ClinicalTrials.gov Identifier: NCT01462227
Recruitment Status : Completed
First Posted : October 31, 2011
Results First Posted : February 18, 2016
Last Update Posted : February 18, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypoglycemia
Interventions Drug: Naltrexone High Dose
Drug: Naltrexone Low Dose
Enrollment 17

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naltrexone (Lower Dose) First /Placebo Second Placebo First/ Naltrexone (Lower Dose) Second Naltrexone (Higher Dose) First /Placebo Second Placebo First / Naltrexone (Higher Dose) Second
Hide Arm/Group Description Naltrexone 50 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally Placebo given given 12 hours prior to visit orally Naltrexone 50 mg (1 tablet) given at time of visit orally Naltrexone 100 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally Placebo given 12 hours prior to visit orally Naltrexone 100 mg (1 tablet) given at time of visit orally
Period Title: First Assignment
Started 4 2 6 5
Completed 4 2 6 5
Not Completed 0 0 0 0
Period Title: Second Assignment
Started 4 2 6 5
Completed 3 1 5 5
Not Completed 1 1 1 0
Reason Not Completed
Lost to Follow-up             1             0             0             0
Protocol Violation             0             1             1             0
Arm/Group Title Naltrexone (Lower Dose) Naltrexone (Higher Dose) Total
Hide Arm/Group Description Naltrexone: Naltrexone 50 mg, 1 tablet given every 12 hours orally Naltrexone: Naltrexone 100mg, 1 tablet given every 12 hours orally Total of all reporting groups
Overall Number of Baseline Participants 4 10 14
Hide Baseline Analysis Population Description
Baseline population includes subjects that completed study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 10 participants 14 participants
32.3  (11) 32.4  (12) 32.4  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 10 participants 14 participants
Female
2
  50.0%
4
  40.0%
6
  42.9%
Male
2
  50.0%
6
  60.0%
8
  57.1%
1.Primary Outcome
Title Glucose (mg/dL)
Hide Description Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Time Frame End of study (up to 240 minutes)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects' data were pooled and only those that completed both visits are analyzed here.
Arm/Group Title Naltrexone (Lower Dose) Naltrexone (Higher Dose)
Hide Arm/Group Description:
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Overall Number of Participants Analyzed 4 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
Active Drug 56.5  (3.7) 52.8  (8.6)
Placebo 55.0  (2.8) 52.8  (8.6)
2.Primary Outcome
Title Glucose Infusion Rate (mg/kg.Min)
Hide Description 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).
Time Frame End of study (up to 240 minutes)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects' data were pooled and only those that completed both visits are analyzed here.
Arm/Group Title Naltrexone (Lower Dose) Naltrexone (Higher Dose)
Hide Arm/Group Description:
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Overall Number of Participants Analyzed 4 10
Mean (Standard Deviation)
Unit of Measure: mg/kg.min
Active Drug 4.6  (2.7) 6.3  (2.4)
Placebo 4.8  (4.0) 5.9  (2.7)
3.Secondary Outcome
Title Glucagon (pg/mL)
Hide Description Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Time Frame End of study (up to 240 minutes)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects' data were pooled and only those that completed both visits are analyzed here.
Arm/Group Title Naltrexone (Lower Dose) Naltrexone (Higher Dose)
Hide Arm/Group Description:
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Overall Number of Participants Analyzed 4 10
Mean (Standard Deviation)
Unit of Measure: pg/mL
Active Drug 44.1  (17.4) 48.9  (16.5)
Placebo 40.4  (7.9) 53.6  (16.4)
4.Secondary Outcome
Title Cortisol (ug/dL)
Hide Description Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Time Frame End of study (up to 240 minutes)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects' data were pooled and only those that completed both visits are analyzed here.
Arm/Group Title Naltrexone (Lower Dose) Naltrexone (Higher Dose)
Hide Arm/Group Description:
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Overall Number of Participants Analyzed 4 10
Mean (Standard Deviation)
Unit of Measure: ug/dL
Active Drug 22.9  (8.3) 16.4  (8.1)
Placebo 16.0  (7.0) 15.2  (5.2)
5.Secondary Outcome
Title Epinephrine (pg/mL)
Hide Description Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Time Frame End of study (up to 240 minutes)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects' data were pooled and only those that completed both visits are analyzed here.
Arm/Group Title Naltrexone (Lower Dose) Naltrexone (Higher Dose)
Hide Arm/Group Description:
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Overall Number of Participants Analyzed 4 10
Mean (Standard Deviation)
Unit of Measure: pg/mL
Active Drug 92.75  (30.6) 126.1  (98.0)
Placebo 42.75  (23.1) 77.9  (65.8)
6.Secondary Outcome
Title Norepinephrine (pg/mL)
Hide Description Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Time Frame End of study (up to 240 minutes)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects' data were pooled and only those that completed both visits are analyzed here.
Arm/Group Title Naltrexone (Lower Dose) Naltrexone (Higher Dose)
Hide Arm/Group Description:
Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
Overall Number of Participants Analyzed 4 10
Mean (Standard Deviation)
Unit of Measure: pg/mL
Active Drug 248.3  (80.2) 200.1  (77.4)
Placebo 282.8  (97.3) 217.1  (91.5)
Time Frame End of study, up to 240 minutes.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone (50 mg) Placebo (Lower Dose Group) Naltrexone (100 mg) Placebo (Higher Dose)
Hide Arm/Group Description Naltrexone 50 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally). Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally). Naltrexone 100 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally). Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
All-Cause Mortality
Naltrexone (50 mg) Placebo (Lower Dose Group) Naltrexone (100 mg) Placebo (Higher Dose)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Naltrexone (50 mg) Placebo (Lower Dose Group) Naltrexone (100 mg) Placebo (Higher Dose)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Naltrexone (50 mg) Placebo (Lower Dose Group) Naltrexone (100 mg) Placebo (Higher Dose)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)      5/10 (50.00%)      3/10 (30.00%)    
Gastrointestinal disorders         
Nausea   0/4 (0.00%)  0 0/4 (0.00%)  0 5/10 (50.00%)  5 2/10 (20.00%)  2
General disorders         
Insomnia   0/4 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
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
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01462227     History of Changes
Other Study ID Numbers: HIC1006006927
First Submitted: October 26, 2011
First Posted: October 31, 2011
Results First Submitted: January 20, 2016
Results First Posted: February 18, 2016
Last Update Posted: February 18, 2016