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Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00990184
First Posted: October 6, 2009
Last Update Posted: November 21, 2012
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.
Collaborator:
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research
Results First Submitted: February 1, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Impaired Fasting Glucose
Prediabetes
Interventions: Drug: Colesevelam
Other: placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Colesevelam Hydrochloride People with IGT will take 2 weeks of placebo and then 8 weeks of study drug

Participant Flow:   Overall Study
    Colesevelam Hydrochloride
STARTED   21 
COMPLETED   20 
NOT COMPLETED   1 
Physician Decision                1 



  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.
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Reporting Groups
  Description
Colesevelam Hydrochloride People with IGT will take 2 weeks of placebo and then 8 weeks of study drug

Baseline Measures
   Colesevelam Hydrochloride 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   6 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.7  (8.7) 
Gender 
[Units: Participants]
 
Female   9 
Male   12 


  Outcome Measures
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1.  Primary:   Acute Insulin Response (AIRg) to Intravenous Glucose   [ Time Frame: Baseline and 8 weeks ]

2.  Secondary:   Insulin Sensitivity   [ Time Frame: Baseline and 8 weeks ]

3.  Secondary:   Glucose Disappearance Rate   [ Time Frame: Baseline and 8 weeks ]


  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:  
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: Steven E. Kahn
Organization: SIBCR
phone: 206-277-5515
e-mail: skahn@u.washington.edu


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

Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT00990184     History of Changes
Other Study ID Numbers: 1.2
First Submitted: October 2, 2009
First Posted: October 6, 2009
Results First Submitted: February 1, 2012
Results First Posted: November 21, 2012
Last Update Posted: November 21, 2012