We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Naltrexone and Hypoglycemia in Type 1 Diabetes (Naltrexone)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01053078
First Posted: January 21, 2010
Last Update Posted: June 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Diabetes Association
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
Results First Submitted: September 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Type 1 Diabetes
Hypoglycemia Unawareness
Intervention: Drug: Naltrexone

  Participant Flow
  Hide Participant Flow

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

Double blind placebo comparable

Naltrexone: 1 month treatment

Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28

Placebo

Naltrexone: 1 month treatment

Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28


Participant Flow:   Overall Study
    Naltrexone   Placebo
STARTED   14   15 
COMPLETED   10   12 
NOT COMPLETED   4   3 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Naltrexone

Double blind placebo comparable

Naltrexone: 1 month treatment

Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28

Placebo

Naltrexone: 1 month treatment

Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28

Total Total of all reporting groups

Baseline Measures
   Naltrexone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   12   22 
Age 
[Units: Years]
Mean (Standard Deviation)
 47  (13)   39  (10)   42  (14) 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   12   22 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   6   6   12 
Male   4   6   10 
Region of Enrollment 
[Units: Participants]
     
United States   10   12   22 


  Outcome Measures

1.  Primary:   Cerebral Blood Flow   [ Time Frame: 1 month ]

2.  Secondary:   Rates of Hypoglycemia   [ Time Frame: 1 month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Elizabeth Seaquist
Organization: University of Minnesota
phone: 612 624 9176
e-mail: seaqu001@umn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01053078     History of Changes
Other Study ID Numbers: Protocol 10087
R01DK062440 ( U.S. NIH Grant/Contract )
7-09-DCS-02 ( Other Grant/Funding Number: American Diabetes Association )
First Submitted: January 19, 2010
First Posted: January 21, 2010
Results First Submitted: September 4, 2014
Results First Posted: September 12, 2014
Last Update Posted: June 27, 2016